MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)

May 3, 2023 updated by: Merck Sharp & Dohme LLC

A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects With Complicated Intra-Abdominal Infection

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.

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.
94

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 2

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
    • Parana
      • Curitiba, Parana, Brazil, 80250-060
        • Hospital Pequeno Principe ( Site 0200)
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0201)
    • Rio Grande Do Sul
      • Bento Goncalves, Rio Grande Do Sul, Brazil, 95700-068
        • Hospital Tacchini ( Site 0203)
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem ( Site 0807)
      • Budapest, Hungary, 1089
        • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0806)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 0801)
      • Szeged, Hungary, 6720
        • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0802)
    • Baranya
      • Pecs, Baranya, Hungary, 7623
        • PTE AOK Klinikai Kozpont ( Site 0805)
    • Szabolcs-Szatmar-Bereg
      • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • SzSzBMK es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz ( Site 0804)
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas ( Site 1001)
      • Klaipeda, Lithuania, 92140
        • Klaipedos Vaiku Ligonine ( Site 1000)
      • Vilnius, Lithuania, 08406
        • Vaiku Ligonine VU ligonines Santariskiu kliniku filialas ( Site 1002)
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre. ( Site 1100)
    • Johor
      • Cheras, Johor, Malaysia, 56000
        • Universiti Kebangsaan Malaya Medical Centre ( Site 1101)
    • Pulau Pinang
      • Georgetown, Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang ( Site 1102)
  • Mexico
      • Mexico City, Mexico, 04530
        • Instituto Nacional de Pediatria ( Site 1201)
      • Mexico City, Mexico, 06720
        • Hospital Infantil de Mexico Federico Gomez ( Site 1202)
    • Morelos
      • Emiliano Zapata, Morelos, Mexico, 62765
        • Hospital del Nino y Adolescente Morelense ( Site 1204)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 1203)
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400370
        • Spit. Cl. de Urg. Copii Cluj Napoca ( Site 1703)
    • Timis
      • Timisoara, Timis, Romania, 300011
        • Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timi ( Site 1701)
  • Russian Federation
    • Chelyabinskaya Oblast
      • Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
        • Chelyabinsk Regional Children Clinical Hospital ( Site 1802)
    • Smolenskaya Oblast
      • Smolensk, Smolenskaya Oblast, Russian Federation, 214018
        • Smolensk Regional Clinical Hospital ( Site 1800)
    • Stavropol Skiy Kray
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 355029
        • Stavropol Regional Pediatric Clinical Hospital ( Site 1805)
    • Vologodskaya Oblast
      • Vologda, Vologodskaya Oblast, Russian Federation, 160022
        • Regional Childrens Clinical Hospital ( Site 1809)
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0208
        • Molotlegi Street ( Site 1901)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Red Cross War Memorial Children's Hospital ( Site 1902)
  • Spain
    • A Coruña [La Coruña]
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
        • Hospital Clinico Universitario de Santiago ( Site 2001)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 2004)
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Hospital Universitario Sant Joan de Deu ( Site 2000)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46026
        • Hospital Universitario la Fe ( Site 2003)
  • Turkey
      • Adana, Turkey, 01330
        • Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 2200)
      • Ankara, Turkey, 06230
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2201)
      • Eskisehir, Turkey, 26480
        • Eskisehir Osmangazi Unv. Tip Fakultesi ( Site 2202)
      • Istanbul, Turkey, 34453
        • SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 2203)
  • Ukraine
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49100
        • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 2452)
      • Kryvyy Rig, Dnipropetrovska Oblast, Ukraine, 50082
        • PI Kryvorizka city clinical hospital 8 ( Site 2458)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76014
        • Ivano-Frankivsk Regional Children Clinical Hospital ( Site 2461)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 01135
        • National Children Specialised Hospital OHMADYT MOH Ukraine ( Site 2459)
    • Poltavska Oblast
      • Poltava, Poltavska Oblast, Ukraine, 36004
        • Municipal Institution City Children s Clinical Hospital of Poltava City Council ( Site 2454)
    • Vinnytska Oblast
      • Vinnytsya, Vinnytska Oblast, Ukraine, 21029
        • Vinnytsya Regional Children Clinical Hospital ( Site 2463)
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital - Los Angeles ( Site 2508)
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County ( Site 2502)
      • San Diego, California, United States, 92123
        • Rady Children's Hospital-San Diego ( Site 2505)
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center/Wolfson Children's Hospital ( Site 2521)
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center-Floating Hospital for Children ( Site 2516)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital ( Site 2511)
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital ( Site 2509)
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital ( Site 2500)
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Childrens Hospital ( Site 2510)

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

1 week to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a legally acceptable representative who provides documented informed consent/assent for the trial.
  • Aged from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18 years of age.
  • Require IV antibacterial therapy for the treatment of presumed or documented cIAI.
  • Has an operative procedure for the current diagnosis and management of cIAI planned or completed within 24 hours of the first dose of an antibacterial drug. Note: Participants with a diagnosis of necrotizing enterocolitis are exempt and not required to have surgery planned or completed in order to be eligible.
  • Has in compliance baseline intra-abdominal specimen collection.
  • Is not of reproductive potential; but if of reproductive potential agrees to avoid becoming pregnant or impregnating a partner during screening, while receiving study treatment and for at least 30 days after the last dose of study treatment.
  • Female of reproductive potential is not pregnant, and not planning to become pregnant within 30 days of the last day of treatment administration; and is nonlactating.

Exclusion Criteria:

  • Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days prior to the first dose of study treatment in this current trial.
  • Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or has enrolled previously in the current trial and been discontinued.
  • Has a history of any moderate or severe hypersensitivity (e.g, anaphylaxis), allergic reaction, or other contraindication to any of the following: β-lactam antibiotics (e.g, penicillins, cephalosporins, and carbapenems), β-lactamase inhibitors (e.g, tazobactam, sulbactam, clavulanic acid, avibactam), or metronidazole.
  • Has an IAI within the past 1 year prior to randomization known to be caused by a pathogen resistant to either IV study treatment.
  • Has a 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.
  • Has received potentially therapeutic antibacterial therapy for a duration more than 24 hours during the 48 hours preceding the first dose of study treatment, unless is considered to be failing antibiotic therapy for cIAI.
  • Has any of the following: a) intractable cIAI that the investigator anticipates would require more than 14 days of study treatment; b) abdominal wall abscess; c) small bowel obstruction; d) ischemic bowel disease without perforation; e) traumatic bowel perforation with surgery within 12 hours of perforation; f) perforation of gastroduodenal ulcers requiring surgery within 24 hours of perforation; g) suspected uncomplicated intra-abdominal infection (e.g, cholecystitis without rupture or extension beyond the gallbladder wall); h) acute suppurative cholangitis; i) infected necrotizing pancreatitis; j) pancreatic abscess.
  • Has moderate or severe impairment of renal function.
  • Has a seizure disorder or is anticipated to be treated with divalproex sodium or valproic acid during the course of study treatment.
  • Is receiving, or is expected to receive, any prohibited medications.
  • Has any rapidly progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure, or septic shock.
  • Has an immunocompromising condition.
  • Has a history of malignancy ≤5 years prior to signing informed consent.
  • Is planning to receive suppressive/prophylactic antibiotics with gram-negative activity after completion of study treatment.

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: Quadruple

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.
Experimental: Ceftolozane/Tazobactam + Metronidazole
Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose), plus metronidazole 10 mg/kg (maximum 1.5 g/day) administered intravenously (IV) every 8 to 12 hours for 5 to 14 days.
Drug: Ceftolozane/Tazobactam
Ceftolozane 20 mg/kg (maximum 1 g) and tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 5 to 14 days.
Other Names:
  • MK-7625A
Drug: Metronidazole
Metronidazole 10 mg/kg (maximum 1.5 g/day) administered IV every 8 hours for between 5 to 14 days. Participants ≤ 28 days old, start with a loading dose of 15 mg/kg; then if ≤ 2 kg are dosed 7.5 mg/kg/ every 12 hours; or if > 2 kg are dosed 10 mg/kg every 8 hours.
Active Comparator: Meropenem + Placebo for Metronidazole
Meropenem 20 mg/kg (maximum 1 g/dose) plus placebo for Metronidazole administered IV every 8 hours for 5 to 14 days.
Drug: Meropenem
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days.
Other Names:
  • MERREM
Drug: Placebo for Metronidazole
Placebo for metronidazole administered IV every 8 hours for between 5 to 14 days.

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
Number of Participants Experiencing ≥1 Adverse Events (AEs)
Time Frame: Up to approximately 75 days
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.
Up to approximately 75 days
Number of Participants Who Discontinued Study Therapy Due to AE(s)
Time Frame: Up to approximately 18 days
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
Up to approximately 18 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 With a Clinical Response of "Cure" at the End of Treatment (EOT) Visit
Time Frame: Up to approximately 27 days
The percentage of participants who had a clinical outcome of "cure" at the time of the EOT visit is presented. The "cure" clinical outcome was defined as complete resolution or marked improvement in signs and symptoms of the complicated intra-abdominal infection (cIAI) or return to pre-infection signs and symptoms such that no further antibiotic therapy (intravenous or oral) or surgical or drainage procedure is required for treatment of the cIAI. Participants who were missing clinical response data were considered treatment failures.
Up to approximately 27 days
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
Time Frame: Up to approximately 39 days
The percentage of participants who had a clinical outcome of "cure" at the time of the TOC visit is presented. The "cure" clinical outcome was defined as complete resolution or marked improvement in signs and symptoms of the complicated intra-abdominal infection (cIAI) or return to pre-infection signs and symptoms such that no further antibiotic therapy (intravenous or oral) or surgical or drainage procedure is required for treatment of the cIAI. Participants who were missing clinical response data were considered treatment failures.
Up to approximately 39 days
Percentage of Participants With Microbiological Eradication at the EOT Visit
Time Frame: Up to approximately 27 days
The percentage of participants who achieved either eradication or presumed eradication of each baseline infecting pathogen by the time of the EOT visit is presented. Eradication was defined as absence of the baseline pathogen(s) in a postbaseline specimen appropriately obtained from the original site of infection. Presumed eradication was defined as absence of material to culture in a participant who is assessed as having partial improvement, or clinical cure. In the event of multiple baseline pathogens, the least favorable microbiological response from all possible baseline pathogens was used.
Up to approximately 27 days
Percentage of Participants With Microbiological Eradication at the TOC Visit
Time Frame: Up to approximately 39 days
The percentage of participants who achieved either eradication or presumed eradication of each baseline infecting pathogen by the time of the TOC visit is presented. Eradication was defined as absence of the baseline pathogen(s) in a postbaseline specimen appropriately obtained from the original site of infection. Presumed eradication was defined as absence of material to culture in a participant who is assessed as having partial improvement, or clinical cure. In the event of multiple baseline pathogens, the least favorable microbiological response from all possible baseline pathogens was used.
Up to approximately 39 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

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.
April 3, 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.
March 16, 2020

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.
March 16, 2020

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).
July 12, 2017

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.
July 12, 2017

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 13, 2017

Study Record Updates

Last Update Posted (Estimate)

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.
May 5, 2023

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.
May 3, 2023

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.
May 1, 2023

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.
  • 7625A-035
  • 2016-004820-41 (EudraCT Number)
  • MK-7625A-035 (Other Identifier: Merck)

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

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.

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Drug Interventions

Conditions

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Locations

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