- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969901
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Toll Free Number
- Phone Number: 1-888-577-8839
- Email: Trialsites@merck.com
Study Locations
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Burgas, Bulgaria, 8127
- Completed
- UMHAT Deva Maria. EOOD ( Site 0165)
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Montana, Bulgaria, 3400
- Completed
- MHAT City Clinic Sv. Georgi EOOD ( Site 0167)
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Pleven, Bulgaria, 5800
- Completed
- UMHAT Dr. Georgi Stranski EAD ( Site 0174)
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Ruse, Bulgaria, 7002
- Recruiting
- UMHAT Kanev AD ( Site 0168)
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Contact:
- Study Coordinator
- Phone Number: +359899975275
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Ruse, Bulgaria, 7002
- Recruiting
- UMHAT Kanev AD ( Site 0169)
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Contact:
- Study Coordinator
- Phone Number: +359888209200
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Sliven, Bulgaria, 8800
- Completed
- MHAT Dr. Ival Seliminski ( Site 0173)
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Region M. De Santiago
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Santiago, Region M. De Santiago, Chile, 8380418
- Recruiting
- Hospital Roberto del Río ( Site 0802)
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Contact:
- Study Coordinator
- Phone Number: 992360000
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Antioquia
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Medellin, Antioquia, Colombia, 050010
- Active, not recruiting
- Fundacion Hospital San Vicente de Paul ( Site 0269)
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Atlantico
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Barranquilla, Atlantico, Colombia, 080020
- Recruiting
- Clinica de la Costa S.A.S. ( Site 0264)
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Contact:
- Study Coordinator
- Phone Number: +573157609110
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Distrito Capital De Bogota
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Bogota, Distrito Capital De Bogota, Colombia, 11001000
- Recruiting
- Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0265)
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Contact:
- Study Coordinator
- Phone Number: +573207532651
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Bogota, Distrito Capital De Bogota, Colombia, 111211
- Recruiting
- Fundacion Hospital Infantil Universitario de San Jose ( Site 0268)
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Contact:
- Study Coordinator
- Phone Number: +573108059791
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760032
- Recruiting
- Fundacion Valle del Lili ( Site 0266)
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Contact:
- Study Coordinator
- Phone Number: +573154896219
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Harjumaa
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Tallinn, Harjumaa, Estonia, 13419
- Recruiting
- Tallinn Children Hospital ( Site 0209)
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Contact:
- Study Coordinator
- Phone Number: +37255573326
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06200
- Recruiting
- Hopitaux Pediatriques CHU Lenval ( Site 0143)
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Contact:
- Study Coordinator
- Phone Number: +33492030579
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Cote-d Or
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Dijon, Cote-d Or, France, 21000
- Completed
- Hopital Francois Mitterand ( Site 0146)
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Nord-Pas-de-Calais
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Lille, Nord-Pas-de-Calais, France, 59120
- Recruiting
- Hopital Jeanne de Flandre ( Site 0145)
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Contact:
- Study Coordinator
- Phone Number: 33320446059
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Thessaloniki, Greece, 546 42
- Recruiting
- Hippokration General Hospital of Thessaloniki ( Site 0244)
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Contact:
- Study Coordinator
- Phone Number: +302310892444
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Attiki
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Athens, Attiki, Greece, 11527
- Recruiting
- Pan and Aglaia Kyriakou Children s Hospital ( Site 0247)
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Contact:
- Study Coordinator
- Phone Number: +302107793000
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Athens, Attiki, Greece, 115 27
- Completed
- University of Athens - Aghia Sophia Childrens Hospital ( Site 0243)
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Hajdu-Bihar
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Debrecen, Hajdu-Bihar, Hungary, 4032
- Recruiting
- Debreceni Egyetem Klinikai Kozpont ( Site 0100)
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Contact:
- Study Coordinator
- Phone Number: +36305769835
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Szabolcs-Szatmar-Bereg
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Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
- Recruiting
- Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0105)
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Contact:
- Study Coordinator
- Phone Number: +36302565180
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Haifa, Israel, 3109601
- Recruiting
- Rambam Medical Center ( Site 0189)
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Contact:
- Study Coordinator
- Phone Number: +97247774810
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Jerusalem, Israel, 9112001
- Recruiting
- Hadassah Ein Karem Hebrew University Medical Center ( Site 0188)
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Contact:
- Study Coordinator
- Phone Number: +97226777111
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Petah Tikva, Israel, 4920235
- Completed
- Schneider Children's Medical Center ( Site 0187)
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Ramat Gan, Israel, 5262100
- Recruiting
- Chaim Sheba Medical Center ( Site 0190)
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Contact:
- Study Coordinator
- Phone Number: +97235305978
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Aguascalientes, Mexico, 20259
- Recruiting
- Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0290)
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Contact:
- Study Coordinator
- Phone Number: +524499946720
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Ciudad de Mexico, Mexico, 04530
- Recruiting
- Instituto Nacional de Pediatria ( Site 0291)
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Contact:
- Study Coordinator
- Phone Number: +525510840900
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Baja California
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Tijuana, Baja California, Mexico, 22000
- Completed
- Hospital General de Tijuana ( Site 0284)
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Morelos
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Emiliano Zapata, Morelos, Mexico, 62765
- Completed
- Hospital del Nino y Adolescente Morelense ( Site 0286)
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Hordaland
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Bergen, Hordaland, Norway, 5009
- Recruiting
- Haukeland Universitetssjukehus ( Site 0500)
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Contact:
- Study Coordinator
- Phone Number: +4755975720
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National Capital Region
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Manila, National Capital Region, Philippines, 1000
- Completed
- University of the Philippines-Philippine General Hospital ( Site 0318)
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Quezon City, National Capital Region, Philippines, 1104
- Completed
- Philippine Children s Medical Center ( Site 0317)
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Kujawsko-pomorskie
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Torun, Kujawsko-pomorskie, Poland, 87-100
- Completed
- Wojewodzki Szpital Zespolony im. Rydgiera ( Site 0220)
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Lodzkie
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Lodz, Lodzkie, Poland, 93-338
- Recruiting
- Instytut Centrum Zdrowia Matki Polki ( Site 0223)
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Contact:
- Study Coordinator
- Phone Number: +48422711391
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Mazowieckie
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Lomianki, Mazowieckie, Poland, 05-092
- Recruiting
- SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0226)
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Contact:
- Study Coordinator
- Phone Number: +48227657153
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Moskva
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Moscow, Moskva, Russian Federation, 117197
- Completed
- Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 0233)
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Moscow, Moskva, Russian Federation, 119049
- Suspended
- Morozovskaya Children City Clinical Hospital ( Site 0241)
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Novosibirskaya Oblast
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Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630011
- Suspended
- State Budgetary Healthcare Institution of Novosibirsk Region City Childrens Clinical Emergency Hospi
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russian Federation, 194100
- Completed
- St.Petersburg State Pediatric Medical University ( Site 0236)
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Saint Petersburg, Sankt-Peterburg, Russian Federation, 198205
- Completed
- Children's City Clinical Hospital #1 ( Site 0237)
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St. Petersburg, Sankt-Peterburg, Russian Federation, 192289
- Suspended
- Children s City Clinical Hospital 5 n.a. N.F. Filatov ( Site 0235)
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Smolenskaya Oblast
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Smolensk, Smolenskaya Oblast, Russian Federation, 214018
- Suspended
- Smolensk Regional Clinical Hospital ( Site 0231)
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Vologodskaya Oblast
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Vologda, Vologodskaya Oblast, Russian Federation, 160022
- Completed
- Regional Childrens Clinical Hospital ( Site 0400)
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Gauteng
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Johannesburg, Gauteng, South Africa, 2013
- Recruiting
- Chris Hani Baragwanath Academic Hospital ( Site 0156)
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Contact:
- Study Coordinator
- Phone Number: +27119330270
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Johannesburg, Gauteng, South Africa, 2001
- Completed
- Empilweni Services and Research Unit ( Site 1557)
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Pretoria, Gauteng, South Africa, 0208
- Recruiting
- Molotlegi Street ( Site 0155)
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Contact:
- Study Coordinator
- Phone Number: +27125215633
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Madrid, Spain, 28009
- Recruiting
- Hospital Infantil Universitario Nino Jesus ( Site 0114)
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Contact:
- Study Coordinator
- Phone Number: +34915035900
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Madrid, Spain, 28046
- Completed
- Hospital Universitario La Paz ( Site 0113)
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Sevilla, Spain, 41043
- Completed
- Hospital Universitario Virgen del Rocio ( Site 0115)
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Adana, Turkey, 01330
- Recruiting
- Cukurova University Medical Faculty ( Site 0200)
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Contact:
- Study Coordinator
- Phone Number: +905326534166
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Ankara, Turkey, 06590
- Completed
- Ankara Universitesi Tip Fakultesi. ( Site 0202)
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Eskisehir, Turkey, 26480
- Recruiting
- Eskisehir Osmangazi University Medical ( Site 0201)
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Contact:
- Study Coordinator
- Phone Number: +905339243269
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Istanbul, Turkey, 34453
- Recruiting
- SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 0198)
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Contact:
- Study Coordinator
- Phone Number: +905055803297
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Izmir, Turkey, 35100
- Completed
- Ege Universitesi Tıp Fakultesi Hastanesi ( Site 0199)
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Dnipropetrovska Oblast
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Dnipro, Dnipropetrovska Oblast, Ukraine, 49100
- Suspended
- SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0121)
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Kryvyy Rig, Dnipropetrovska Oblast, Ukraine, 50082
- Completed
- Communal non-commercial enterprise "Kryvorizka city clinical hospital 16" of Kryvyy Rig city council
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Ivano-Frankivska Oblast
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Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76014
- Recruiting
- Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0131)
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Contact:
- Study Coordinator
- Phone Number: +380681040592
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Kharkivska Oblast
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Kharkiv, Kharkivska Oblast, Ukraine, 61075
- Suspended
- Kharkiv City Children Hospital 16 ( Site 0130)
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Poltavska Oblast
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Poltava, Poltavska Oblast, Ukraine, 36004
- Suspended
- Municipal Enterprise Children's City Clinical Hospital in Poltava City Council ( Site 0122)
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Arizona
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Tucson, Arizona, United States, 85724
- Completed
- Banner University Medical Center ( Site 0356)
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California
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Long Beach, California, United States, 90806
- Completed
- Miller Children's & Women's Hospital ( Site 0349)
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San Diego, California, United States, 92123
- Recruiting
- Rady Children's Hospital-San Diego ( Site 0347)
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Contact:
- Study Coordinator
- Phone Number: 858-966-8381
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Completed
- Tufts Medical Center-Floating Hospital for Children ( Site 0350)
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Completed
- University of New Mexico ( Site 0358)
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Texas
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San Antonio, Texas, United States, 78229
- Recruiting
- University Hospital ( Site 0360)
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Contact:
- Study Coordinator
- Phone Number: 210-567-5262
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Virginia
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Richmond, Virginia, United States, 23298
- Completed
- Children's Hospital of Richmond at VCU ( Site 0359)
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West Virginia
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Morgantown, West Virginia, United States, 26506
- Recruiting
- West Virginia University Ruby Memorial Hospital ( Site 0344)
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Contact:
- Study Coordinator
- Phone Number: 304-293-1201
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Requires hospitalization and treatment with IV antibacterial therapy for confirmed or suspected gram-negative bacterial infection (in the absence of meningitis), and is expected to require hospitalization through completion of IV study intervention, with at least 1 of the following primary infection types: HABP or VABP; cIAI; or cUTI.
- For Age Cohorts 4 and 5, participant is at least 37 weeks postmenstrual age at the time of signing the informed consent/assent.
- If female, must not be pregnant or breastfeeding, and at least 1 of the following conditions must apply: must not be a woman of childbearing potential (WOCBP); OR, if a WOCBP, must agree to follow contraceptive guidance during the intervention period and for at least 24 hours after the last dose of study intervention.
- Has sufficient intravascular access to receive study drug through an existing peripheral or central line.
Exclusion Criteria:
- Is expected to survive less than 72 hours.
- Has a concurrent infection that would interfere with evaluation of response to the study antibacterials (IMI/REL or Active Control), including any of the following: endocarditis; osteomyelitis; meningitis; prosthetic joint infection; active pulmonary tuberculosis; disseminated fungal infection; concomitant infection at the time of randomization that requires non-study systemic antibacterial therapy in addition to IV study treatment or oral step-down therapy (medications with only gram-positive activity [e.g., vancomycin, linezolid] are allowed).
- Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction.
- Has a cUTI, with any of the following: complete obstruction of any portion of the urinary tract (ie, requiring a permanent indwelling urinary catheter or instrumentation); documented reflux of ileal loop urinary diversion; suspected or confirmed perinephric or intrarenal abscess; suspected or confirmed prostatitis, urethritis, or epididymitis; trauma to pelvis/urinary tract; presence of indwelling urinary catheter which cannot be removed at study entry.
- Has any of the following medical conditions at screening: history of a seizure disorder (requiring ongoing treatment with anti-convulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years); cystic fibrosis; history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to IMI, or to any carbapenem, cephalosporin, penicillin, or other β-lactam agent, or to other β-lactamase inhibitors (eg, tazobactam, sulbactam, clavulanic acid, avibactam).
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound study results, or interfere with the participant's participation for the full duration of the study.
- If less than 3 months of age, has received more than 72 hours of empiric antibacterial treatment for suspected meningitis prior to initiation of IV study intervention.
- If 3 months of age or older, or <3 months of age without suspected meningitis, has received potentially therapeutic antibacterial therapy (eg, with gram-negative activity), including bladder infusions with topical urinary antiseptics or antibacterial agents, for a duration of more than 24 hours during the 48 hours preceding the first dose of study intervention.
- Is anticipated to be treated with any of the following medications: valproic acid or divalproex sodium (or has used valproic acid or divalproex sodium in the 2 weeks prior to screening) through 24 hours after completion of the final dose of IV study intervention for participants who receive IMI/REL or carbapenem; concomitant IV, oral, or inhaled antimicrobial agents with gram-negative activity, in addition to those designated in the study intervention groups, during the course of all (IV/oral) study intervention; planned receipt of suppressive/prophylactic antibiotics with gram-negative activity after completion of study intervention.
- Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to screening.
- Has enrolled previously in the current study and been discontinued, or has received REL for any other reason.
- Has an estimated creatinine clearance (based on the Cockcroft-Gault equation, for participants ≥12 years of age) or estimated glomerular filtration rate (eGFR, based on the modified Schwartz equation, for participants <12 years of age) below that specified for the appropriate age range; or requires peritoneal dialysis, hemodialysis, or hemofiltration.
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × upper limit of normal (ULN) at the time of screening. NOTE: Patients with acute hepatic failure or acute decompensation of chronic hepatic failure should also be excluded.
- Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
- Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: IMI/REL
Participants with cIAI or cUTI will receive imipenem/cilastatin/relebactam (IMI/REL) via IV infusion, once every 6 hours, for a minimum of 5 days (with optional oral switch after 3 days) up to a maximum of 14 days.
Participants with HABP/VABP will receive IMI/REL via IV infusion, once every 6 hours, for a minimum of 7 days up to a maximum of 14 days.
All oral switch medications will be chosen from a list of acceptable approved agents and will be administered per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.
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Age-based dosing:
Other Names:
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Active Comparator: Active Control
Participants with cIAI or cUTI will receive active control via IV infusion for a minimum of 5 days (with optional oral switch after 3 days) up to a maximum of 14 days.
Participants with HABP/VABP will receive active control via IV infusion for a minimum of 7 days up to a maximum of 14 days.
All active control and oral switch medications will be administered per authorized PI, SPC, or international treatment guidelines.
All active control and oral switch medications will be chosen from a list of acceptable approved agents.
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All active control medications will be chosen from a list of acceptable approved agents for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines. NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention. All oral switch medications will be chosen from a list of acceptable approved agents. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With One or More Adverse Event (AE)
Time Frame: Up to 28 days
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
The percentage of participants with AEs will be presented.
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Up to 28 days
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Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE)
Time Frame: Up to 14 days
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
The percentage of participants who discontinued study medication due to an AE will be presented.
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Up to 14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Deaths by All Causes Through Day 28
Time Frame: Up to Day 28
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All-cause mortality up to 28 days post-randomization will be presented.
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Up to Day 28
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Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT)
Time Frame: Day 5 up to Day 14
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The percentage of participants with a favorable clinical response at EOT will be presented.
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Day 5 up to Day 14
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Percentage of Participants With a Favorable Clinical Response at Early Follow-Up (EFU)
Time Frame: Day 12 up to Day 28
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The percentage of participants with a favorable clinical response at EFU will be presented.
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Day 12 up to Day 28
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Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU)
Time Frame: Day 19 up to Day 42
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The percentage of participants with a favorable clinical response at LFU will be presented.
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Day 19 up to Day 42
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Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT)
Time Frame: Day 5 up to Day 14
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The percentage of participants with a favorable microbiological response at EOT will be presented.
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Day 5 up to Day 14
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Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU)
Time Frame: Day 12 up to Day 28
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The percentage of participants with a favorable microbiological response at EFU will be presented.
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Day 12 up to Day 28
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Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU)
Time Frame: Day 19 up to Day 42
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Percentage of participants with a favorable microbiological response at LFU will be presented.
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Day 19 up to Day 42
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Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Imipenem Following Administration of IMI/REL
Time Frame: On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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Blood samples for AUC0-24 of imipenem analysis will be collected on Day 1 at 30 minutes prior to start of first dose of IV study intervention, within 10 minutes after the end of the first infusion, and 2 to 6 hours after the start of first infusion; and once at the on-therapy (OTX) visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Relebactam Following Administration of IMI/REL
Time Frame: On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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Blood samples for AUC0-24 of relebactam analysis will be collected on Day 1 at 30 minutes prior to start of first dose of IV study intervention, within 10 minutes after the end of the first infusion, and 2 to 6 hours after the start of first infusion; and once at the on-therapy (OTX) visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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Concentration at End of Infusion (Ceoi) of Imipenem Following Administration of IMI/REL
Time Frame: At the end of the first infusion on Day 1.
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Blood samples for Ceoi of imipenem analysis will be collected within 10 minutes after the end of the first infusion on Day 1.
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At the end of the first infusion on Day 1.
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Concentration at End of Infusion (Ceoi) of Relabactam Following Administration of IMI/REL
Time Frame: At the end of the first infusion on Day 1.
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Blood samples for Ceoi of relabactam analysis will be collected within 10 minutes after the end of the first infusion on Day 1.
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At the end of the first infusion on Day 1.
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Percentage of Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%T>MIC of Imipenem) Following Administration of IMI/REL
Time Frame: On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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Blood samples for %T>MIC of imipenem analysis will be collected on Day 1 at 30 minutes prior to start of first dose of IV study intervention, within 10 minutes after the end of the first infusion, and 2 to 6 hours after the start of first infusion; and once at the on-therapy (OTX) visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections and Mycoses
- Infections
- Communicable Diseases
- Bacterial Infections
- Gram-Negative Bacterial Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Relebactam
Other Study ID Numbers
- 7655A-021
- MK-7655A-021 (Other Identifier: Merck)
- 2019-000338-20 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Suspected or Documented Gram-negative Bacterial Infection
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Merck Sharp & Dohme LLCCompletedSuspected or Documented Gram-negative Bacterial InfectionUnited States, Bulgaria, Colombia, Greece, Norway, Poland, Ukraine, United Kingdom
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Cubist Pharmaceuticals LLCCompletedProven or Suspected Gram-negative Bacterial Infection | Peri-operative Prophylaxis
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Institute of Tropical Medicine, BelgiumSRI International; Sihanouk Hospital Center of HOPECompletedSystemic Inflammatory Response Syndrome | Melioidosis | Suspected or Confirmed Bloodstream InfectionsCambodia
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PfizerAllerganTerminatedGram-negative Bacterial InfectionUnited States, Hungary, Slovakia, Taiwan, India, Estonia, Greece, Italy
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PfizerCompletedGram-negative Bacterial InfectionAustralia
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Seoul National University HospitalCompletedMultidrug-resistant Gram-negative Bacteria InfectionKorea, Republic of
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UMC UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedInfection Resistant to Drugs | Gram-Negative Bacterial InfectionNetherlands
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PfizerRecruitingGram-negative Bacterial InfectionsSpain, Taiwan, United States, Hungary, India, China, Turkey, Greece, Czechia
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Parc de Salut MarCompletedMultidrug Resistant Gram Negative Bacterial InfectionsSpain
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Theravance BiopharmaCompletedSerious Infections Due to Known or Suspected Gram-positive PathogensUnited States
Clinical Trials on IMI/REL
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Ruijin HospitalRecruiting
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Merck Sharp & Dohme LLCCompletedHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial PneumoniaMexico, Brazil, China, France, Philippines, Romania, Russian Federation, Ukraine
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Relmada Therapeutics, Inc.CompletedMajor Depressive DisorderUnited States
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Merck Sharp & Dohme LLCCompletedSuspected or Documented Gram-negative Bacterial InfectionUnited States, Bulgaria, Colombia, Greece, Norway, Poland, Ukraine, United Kingdom
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Merck Sharp & Dohme LLCCompletedComplicated Intra-abdominal Infection | Complicated Urinary Tract InfectionJapan
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Relmada Therapeutics, Inc.CompletedMajor Depressive DisorderUnited States
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Relmada Therapeutics, Inc.RecruitingDepression | Major Depressive DisorderUnited States
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Relmada Therapeutics, Inc.AvailableDepression | Major Depressive Disorder
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Relmada Therapeutics, Inc.RecruitingDepression | Major Depressive DisorderUnited States
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Relmada Therapeutics, Inc.CompletedMajor Depressive DisorderUnited States