Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

January 15, 2025 updated by: Merck Sharp & Dohme LLC

A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) [IMI/REL, MK-7655A] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte ( Site 0300)
    • Sao Paulo
      • Sao Jose Do Rio Preto - SP, Sao Paulo, Brazil, 15090-000
        • Hospital de Base de Sao Jose de Rio Preto ( Site 0301)
  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Beijing Chaoyang Hospital ( Site 0126)
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital ( Site 0131)
      • Beijing, Beijing, China, 100049
        • Aero Space center hospital ( Site 0118)
      • Beijing, Beijing, China, 100073
        • The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157)
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital ( Site 0115)
      • Beijing, Beijing, China, 100730
        • Beijing Hospital ( Site 0127)
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136)
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Affiliated to Xiamen University ( Site 0133)
      • Zhangzhou, Fujian, China, 363000
        • Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( Site 0150)
    • Guangdong
      • GuangZhou, Guangdong, China, 510080
        • The First Affiliated Hospital ( Site 0100)
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University ( Site 0123)
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital ( Site 0101)
      • Guangzhou, Guangdong, China, 510280
        • Zhujiang Hospital of Southern Medical University ( Site 0148)
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital ( Site 0120)
      • Huizhou, Guangdong, China
        • Huizhou Municipal Central Hospital ( Site 0140)
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People s Hospital ( Site 0134)
    • Guangxi
      • Nanning, Guangxi, China, 530022
        • The first people s hospital of Nanning ( Site 0138)
      • Nanning, Guangxi, China, 530022
        • The first people s hospital of Nanning ( Site 0141)
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital ( Site 0106)
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University ( Site 0121)
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Shiyan City People's Hospital-Neurosurgery ( Site 0155)
    • Hunan
      • Changsha, Hunan, China, 410004
        • Changsha Central Hospital ( Site 0119)
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People Hospital ( Site 0122)
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • The First People's Hospital of Changzhou ( Site 0139)
      • Huai'an, Jiangsu, China, 223300
        • First Huai'an Hospital Affiliated to Nanjing Medical University-Neurosurgery Department ( Site 0153)
      • Suzhou, Jiangsu, China, 215008
        • First Hospital Affiliated to Suzhou University ( Site 0111)
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital ( Site 0124)
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University ( Site 0147)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital ( Site 0129)
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 0132)
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University-Neurosurgery Department ( Site 0151)
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Affiliated Hospital of China Medical University ( Site 0116)
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University ( Site 0135)
    • Shandong
      • Liaocheng, Shandong, China, 252000
        • People's Hospital of Liaocheng City-Neurology ( Site 0154)
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine ( Site 0104)
      • Shanghai, Shanghai, China, 200040
        • Huadong Hospital Affiliated Fudan University ( Site 0103)
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital of Fudan University ( Site 0105)
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital ( Site 0125)
      • Shanghai, Shanghai, China, 200443
        • Shanghai Pulmonary Hospital ( Site 0108)
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital ( Site 0113)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital.Zhejiang University ( Site 0102)
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 0110)
      • Lishui, Zhejiang, China, 323000
        • People s Hospital of Lishui City ( Site 0137)
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital-neurosurgery ( Site 0152)
      • Wenzhou, Zhejiang, China, 325000
        • The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0130)
  • France
    • Nord
      • Lille, Nord, France, 59037
        • Hopital Roger Salengro du Lille ( Site 0601)
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44093
        • CHU de Nantes - Hotel Dieu ( Site 0600)
    • Rhone
      • Pierre Benite, Rhone, France, 69495
        • Hospices Civils de Lyon ( Site 0603)
    • Val-de-Marne
      • Le Kremlin-Bicetre, Val-de-Marne, France, 94270
        • Hopital Bicetre ( Site 0605)
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
      • Guadalajara, Jalisco, Mexico, 44340
        • Hospital Civil Nuevo de Guadalajara Dr. Juan I. Menchaca ( Site 0804)
  • Philippines
      • Iloilo, Philippines, 5000
        • West Visayas State University Medical Center ( Site 0900)
    • National Capital Region
      • Metro Manila, National Capital Region, Philippines, 1012
        • Mary Johnston Hospital ( Site 0901)
      • Quezon, National Capital Region, Philippines, 1104
        • Lung Center of the Philippines ( Site 0903)
  • Romania
      • Bucuresti, Romania, 041915
        • Spitalul Clinic de Urgenta Bagdasar-Arseni ( Site 1101)
    • Timis
      • Timisoara, Timis, Romania, 300723
        • Spitalul Clinic Judetean de Urgenta Pius Branzeu ( Site 1103)
  • Russian Federation
    • Arkhangel Skaya Oblast
      • Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation, 163001
        • First City Clinical Hospital n.a. E.E.Volosevich ( Site 1016)
      • Severodvinsk, Arkhangel Skaya Oblast, Russian Federation, 164500
        • City Hospital #2 Severodvinsk ( Site 1017)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 192242
        • Research Institute of Emergency Medicine n.a. I.I.Dzhanelidze ( Site 1011)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194291
        • Clinical Hospital #122 L.G. Sokolova FMBA ( Site 1015)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 196247
        • City Hospital #26 ( Site 1002)
  • Ukraine
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49006
        • ME Dnipropetrovsk Clinical Joinder of Emergency Care of DRC ( Site 1304)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76008
        • Ivano-Frankivsk regional clinical hospital ( Site 1301)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61124
        • City Clinical Hospital No13 of Kharkiv City Council ( Site 1303)
    • Kyivska Oblast
      • Kiev, Kyivska Oblast, Ukraine, 01133
        • Kiyv city municipal hospital 17 ( Site 1300)
    • Poltavska Oblast
      • Poltava, Poltavska Oblast, Ukraine, 36000
        • Reg. Clin. Hospital ( Site 1306)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Requires treatment with IV antibiotic therapy for HABP or VABP
  • Fulfills clinical and radiographic criteria within 48 hours prior to randomization, with onset of criteria occurring after more than 2 days of hospitalization or within 7 days after discharge from a hospital for HABP; or at least 2 days after mechanical ventilation (for VABP)
  • Has an adequate baseline (at or within 2 days of screening) lower respiratory tract specimen obtained for Gram stain and culture
  • Has an infection known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the IV study therapy
  • Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing and long-term storage
  • Males agree to use contraception as detailed in protocol from the time of providing informed consent through completion of the study and refrain from donating sperm during this period
  • Females are not pregnant, not breastfeeding, and are either: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance from the time of providing informed consent through completion of the study
  • If a penicillin skin test is required by local clinical practice, the participant must have a negative skin test result for allergy to penicillin

Exclusion Criteria:

  • Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only
  • Has confirmed or suspected community-acquired bacterial pneumonia (CABP)
  • Has confirmed or suspected pneumonia caused by Mycoplasma, Chlamydia, or Legionella, or of viral, fungal, or parasitic etiology
  • 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 carcinoid tumor or carcinoid syndrome
  • Has active immunosuppression
  • Is expected to die during the 7- to 14-day treatment period, despite adequate antibiotic therapy
  • Has a concurrent condition or infection that, in the investigator's judgment, would preclude evaluation of therapeutic response
  • Has a history of serious allergy, hypersensitivity, or any serious reaction to any β-lactams or β-lactamase inhibitors
  • Has a history of a seizure disorder which has required ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years
  • Is currently undergoing hemodialysis or peritoneal dialysis
  • A WOCBP who has a positive urine pregnancy test at screening
  • Has received effective antibacterial drug therapy with known coverage of pathogens that cause HABP/VABP for a continuous duration of more than 48 hours during the previous 72 hours
  • Is anticipated to be treated with any of the prohibited medications during the course of study therapy
  • Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 90 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial
  • Has previously participated in this study at any time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PIP/TAZ FDC
Piperacillin/tazobactam (PIP/TAZ ) administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
Drug: Linezolid
Open-label 600 mg Linezolid
Drug: PIP/TAZ FDC
4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial
Experimental: IMI/REL FDC
Imipenem/cilastatin/relebactam (IMI/REL) administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
Drug: IMI/REL FDC
500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial
Other Names:
  • MK-7655A
Drug: Linezolid
Open-label 600 mg Linezolid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population
Time Frame: Up to approximately 28 days
For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented.
Up to approximately 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population
Time Frame: Up to approximately 27 days
Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented.
Up to approximately 27 days
Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population
Time Frame: Up to approximately 27 days
Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented.
Up to approximately 27 days
Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population
Time Frame: Up to approximately 14 days
Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy was required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented.
Up to approximately 14 days
Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population
Time Frame: Up to approximately 14 days
Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy is required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented.
Up to approximately 14 days
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population
Time Frame: Up to approximately 14 days
Favorable overall microbiological response rates were defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented.
Up to approximately 14 days
Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population.
Time Frame: Up to approximately 27 days
A favorable by-pathogen microbiological response at EFU visit required "eradication" (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented.
Up to approximately 27 days
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population
Time Frame: Up to approximately 14 days
Favorable overall microbiological response rates was defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented.
Up to approximately 14 days
Percentage of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 98 days
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm.
Up to approximately 98 days
Percentage of Participants Discontinuing Study Drug Due to AEs
Time Frame: Up to approximately 14 days
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm.
Up to approximately 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7655A-016
  • MK-7655A-016 (Other Identifier: MSD Protocol Number)
  • PHRR190814-002177 (Registry Identifier: PHRR)
  • 2018-003202-82 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hospital-Acquired Bacterial Pneumonia

Clinical Trials on IMI/REL FDC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings