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Complicated Intra-Abdominal InfectionPhase 2NCT03217136

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

A Phase 2 study testing Ceftolozane/Tazobactam, Metronidazole and Meropenem in people with Complicated Intra-Abdominal Infection, run by Merck Sharp & Dohme LLC at 50 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 7 days to 17 years
Conditions the study is for
Complicated Intra-Abdominal Infection
What is being tested?
Ceftolozane/Tazobactam, Metronidazole and Meropenem
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
50 sitesin 12 countries
Study dates
3 Apr 2018to 16 Mar 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 days to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

50 sites in 12 countries.

50 sites in 12 countries

United States9 sites

  • Tufts Medical Center-Floating Hospital for Children ( Site 2516)

    Boston, Massachusetts, 02111

  • Baptist Medical Center/Wolfson Children's Hospital ( Site 2521)

    Jacksonville, Florida, 32207

  • Children's Hospital - Los Angeles ( Site 2508)

    Los Angeles, California, 90027

  • Children's Hospital of Orange County ( Site 2502)

    Orange, California, 92868

  • Primary Children's Hospital ( Site 2500)

    Salt Lake City, Utah, 84113

  • Rady Children's Hospital-San Diego ( Site 2505)

    San Diego, California, 92123

  • Seattle Childrens Hospital ( Site 2510)

    Seattle, Washington, 98105

  • St. Louis Children's Hospital ( Site 2511)

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University Hospital ( Site 2509)

    Syracuse, New York, 13210

Other trials in United States

Hungary6 sites

  • Semmelweis Egyetem ( Site 0807)

    Budapest, 1083

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0806)

    Budapest, 1089

  • Debreceni Egyetem Klinikai Kozpont ( Site 0801)

    Debrecen, 4032

  • SzSzBMK es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz ( Site 0804)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • PTE AOK Klinikai Kozpont ( Site 0805)

    Pécs, Baranya, 7623

  • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0802)

    Szeged, 6720

Other trials in Hungary

Ukraine6 sites

  • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 2452)

    Dnipro, Dnipropetrovsk Oblast, 49100

  • Ivano-Frankivsk Regional Children Clinical Hospital ( Site 2461)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014

  • PI Kryvorizka city clinical hospital 8 ( Site 2458)

    Kryvyy Rig, Dnipropetrovsk Oblast, 50082

  • National Children Specialised Hospital OHMADYT MOH Ukraine ( Site 2459)

    Kyiv, Kyivska Oblast, 01135

  • Municipal Institution City Children s Clinical Hospital of Poltava City Council ( Site 2454)

    Poltava, Poltava Oblast, 36004

  • Vinnytsya Regional Children Clinical Hospital ( Site 2463)

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

Mexico4 sites

  • Hospital del Nino y Adolescente Morelense ( Site 1204)

    Emiliano Zapata, Morelos, 62765

  • Instituto Nacional de Pediatria ( Site 1201)

    Mexico City, 04530

  • Hospital Infantil de Mexico Federico Gomez ( Site 1202)

    Mexico City, 06720

  • Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 1203)

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Russia4 sites

  • Chelyabinsk Regional Children Clinical Hospital ( Site 1802)

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Smolensk Regional Clinical Hospital ( Site 1800)

    Smolensk, Smolensk Oblast, 214018

  • Stavropol Regional Pediatric Clinical Hospital ( Site 1805)

    Stavropol, Stavropol Kray, 355029

  • Regional Childrens Clinical Hospital ( Site 1809)

    Vologda, Vologda Oblast, 160022

Other trials in Russia

Spain4 sites

  • Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 2004)

    Badalona, Barcelona, 08916

  • Hospital Universitario Sant Joan de Deu ( Site 2000)

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Clinico Universitario de Santiago ( Site 2001)

    Santiago de Compostela, A Coruña [La Coruña], 15706

  • Hospital Universitario la Fe ( Site 2003)

    Valencia, Valenciana, Comunitat, 46026

Other trials in Spain

Turkey (Türkiye)4 sites

  • Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 2200)

    Adana, 01330

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2201)

    Ankara, 06230

  • Eskisehir Osmangazi Unv. Tip Fakultesi ( Site 2202)

    Eskişehir, 26480

  • SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 2203)

    Istanbul, 34453

Other trials in Turkey (Türkiye)

Brazil3 sites

  • Hospital Tacchini ( Site 0203)

    Bento Gonçalves, Rio Grande do Sul, 95700-068

  • Hospital Pequeno Principe ( Site 0200)

    Curitiba, Paraná, 80250-060

  • Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0201)

    Recife, Pernambuco, 50070-550

Other trials in Brazil

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas ( Site 1001)

    Kaunas, 50161

  • Klaipedos Vaiku Ligonine ( Site 1000)

    Klaipėda, 92140

  • Vaiku Ligonine VU ligonines Santariskiu kliniku filialas ( Site 1002)

    Vilnius, 08406

Other trials in Lithuania

Malaysia3 sites

  • Universiti Kebangsaan Malaya Medical Centre ( Site 1101)

    Cheras, Johor, 56000

  • Hospital Pulau Pinang ( Site 1102)

    George Town, Pulau Pinang, 10990

  • University Malaya Medical Centre. ( Site 1100)

    Kuala Lumpur, 59100

Other trials in Malaysia

Romania2 sites

  • Spit. Cl. de Urg. Copii Cluj Napoca ( Site 1703)

    Cluj-Napoca, Cluj, 400370

  • Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timi ( Site 1701)

    Timișoara, Timiș County, 300011

Other trials in Romania

South Africa2 sites

  • Red Cross War Memorial Children's Hospital ( Site 1902)

    Cape Town, Western Cape, 7700

  • Molotlegi Street ( Site 1901)

    Pretoria, Gauteng, 0208

Other trials in South Africa

About this study

Official title: 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.

Being tested
Ceftolozane/Tazobactam, Metronidazole, Meropenem, Placebo for Metronidazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ceftolozane/TazobactamDrug

    Also called MK-7625A

    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.

  • MetronidazoleDrug

    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.

  • MeropenemDrug

    Also called MERREM

    Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days.

  • Placebo for MetronidazoleDrug

    Placebo for metronidazole administered IV every 8 hours for between 5 to 14 days.

Study groups in NCT03217136
Study groupRoleWhat they receive
Ceftolozane/Tazobactam + MetronidazoleExperimentalCeftolozane 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.
Receives: Drug: Ceftolozane/Tazobactam; Drug: Metronidazole
Meropenem + Placebo for MetronidazoleActive comparatorMeropenem 20 mg/kg (maximum 1 g/dose) plus placebo for Metronidazole administered IV every 8 hours for 5 to 14 days.
Receives: Drug: Meropenem; Drug: Placebo for Metronidazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing ≥1 Adverse Events (AEs)

    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.

    Measured: Up to approximately 75 days

  2. Number of Participants Who Discontinued Study Therapy Due to AE(s)

    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.

    Measured: Up to approximately 18 days

Secondary outcomes (4)

  1. Percentage of Participants With a Clinical Response of "Cure" at the End of Treatment (EOT) Visit

    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.

    Measured: Up to approximately 27 days

  2. Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit

    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.

    Measured: Up to approximately 39 days

  3. Percentage of Participants With Microbiological Eradication at the EOT Visit

    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.

    Measured: Up to approximately 27 days

  4. Percentage of Participants With Microbiological Eradication at the TOC Visit

    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.

    Measured: Up to approximately 39 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start3 Apr 2018
  3. Primary completion16 Mar 2020
  4. Study completion16 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03217136
Sponsor's protocol ID
7625A-035
Other IDs
MK-7625A-035, 2016-004820-41, 2016
Status last verified
May 2023
First submitted
12 Jul 2017
Last updated
6 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Jackson CA, Newland J, Dementieva N, Lonchar J, Su FH, Huntington JA, Bensaci M, Popejoy MW, Johnson MG, De Anda C, Rhee EG, Bruno CJ. Safety and Efficacy of Ceftolozane/Tazobactam Plus Metronidazole Versus Meropenem From a Phase 2, Randomized Clinical Trial in Pediatric Participants With Complicated Intra-abdominal Infection. Pediatr Infect Dis J. 2023 Jul 1;42(7):557-563. doi: 10.1097/INF.0000000000003911. Epub 2023 Mar 29.

    PubMed 37000942

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ceftolozane/Tazobactam, Metronidazole and Meropenem in people with Complicated Intra-Abdominal Infection, run by Merck Sharp & Dohme LLC at 50 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Hungary, Ukraine, Mexico, Russia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing ≥1 Adverse Events (AEs) (time frame: Up to approximately 75 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03217136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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