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New antibiotic shows promise for kids with tough infections

NCT ID NCT03969901

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new antibiotic called MK-7655A in 115 children from birth to 18 years old who had serious bacterial infections. The goal was to see if the drug is safe and works better than standard treatments. Children were randomly assigned to receive either the new drug or an existing antibiotic. The study looked at side effects, survival rates, and how well the infection cleared up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

115 people

The number who actually took part.

Started

Oct 2019

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria include but are not limited to: * Requires hospitalization and treatment with intravenous (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: Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (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: Exclusion Criteria include but are not limited to: * Is expected to survive less than 72 hours. * Has a concurrent infection that would interfere with evaluation of response to the study antibacterials (imipenem/cilastatin/relebactam (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 (i.e., 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 (e.g., anaphylaxis), or any serious reaction to IMI, or to any carbapenem, cephalosporin, penicillin, or other β-lactam agent, or to other β-lactamase inhibitors (e.g., 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. * For all Age Cohorts, provided all other eligibility criteria are met, the following participants may be enrolled: * A participant failing prior antibiotic therapy for a current episode of cUTI or HABP/VABP who: Has received the prior antibacterial treatment for at least 48 hours; Has persistent clinical or radiographic findings clearly indicating ongoing infection; Fulfills other laboratory or microbiology criteria for enrollment * A participant failing prior antibiotic therapy for a current episode of cIAI who: Has received the prior antibacterial treatment for at least 48 hours; Has persistent clinical or radiographic findings clearly indicating ongoing infection; Fulfills other laboratory or microbiology criteria for enrollment; Has planned operative intervention no more than 24 hours after first dose of study treatment; Has not received any further nonstudy antibiotics postoperatively * If 3 months of age or older, or \<3 months of age without suspected meningitis, has received potentially therapeutic antibacterial therapy (e.g., 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 (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

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Conditions

The condition(s) this trial relates to.

gram-negative bacterial infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Suspected or documented gram-negative bacterial infection

Contacts and locations

Locations

  • Ankara Universitesi Tip Fakultesi. ( Site 0202)

    Ankara, 06590, Turkey (Türkiye)

  • Banner University Medical Center ( Site 0356)

    Tucson, Arizona, 85724, United States

  • Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0290)

    Aguascalientes, 20259, Mexico

  • Chaim Sheba Medical Center ( Site 0190)

    Ramat Gan, 5262100, Israel

  • Children s City Clinical Hospital 5 n.a. N.F. Filatov ( Site 0235)

    Saint Petersburg, Sankt-Peterburg, 192289, Russia

  • Children's City Clinical Hospital #1 ( Site 0237)

    Saint Petersburg, Sankt-Peterburg, 198205, Russia

  • Children's Hospital of Richmond at VCU ( Site 0359)

    Richmond, Virginia, 23298, United States

  • Chris Hani Baragwanath Academic Hospital ( Site 0156)

    Johannesburg, Gauteng, 2013, South Africa

  • Clinica de la Costa S.A.S. ( Site 0264)

    Barranquilla, Atlántico, 080020, Colombia

  • Communal non-commercial enterprise "Kryvorizka city clinical hospital 16" of Kryvyy Rig city council

    Kryvyy Rig, Dnipropetrovsk Oblast, 50082, Ukraine

  • Cukurova University Medical Faculty ( Site 0200)

    Adana, 01330, Turkey (Türkiye)

  • Debreceni Egyetem Klinikai Kozpont ( Site 0100)

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Ege Universitesi Tıp Fakultesi Hastanesi ( Site 0199)

    Izmir, 35100, Turkey (Türkiye)

  • Empilweni Services and Research Unit ( Site 1557)

    Johannesburg, Gauteng, 2001, South Africa

  • Eskisehir Osmangazi University Medical ( Site 0201)

    Eskişehir, 26480, Turkey (Türkiye)

  • Fundacion Hospital Infantil Universitario de San Jose ( Site 0268)

    Bogotá, Bogota D.C., 111211, Colombia

  • Fundacion Hospital San Vicente de Paul ( Site 0269)

    Medellín, Antioquia, 050010, Colombia

  • Fundacion Valle del Lili ( Site 0266)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Hadassah Ein Karem Hebrew University Medical Center ( Site 0188)

    Jerusalem, 9112001, Israel

  • Haukeland Universitetssjukehus ( Site 0500)

    Bergen, Hordaland, 5009, Norway

  • Hippokration General Hospital of Thessaloniki ( Site 0244)

    Thessaloniki, 546 42, Greece

  • Hopital Francois Mitterand ( Site 0146)

    Dijon, Cote-d Or, 21000, France

  • Hopital Jeanne de Flandre ( Site 0145)

    Lille, Hauts-de-France, 59120, France

  • Hopitaux Pediatriques CHU Lenval ( Site 0143)

    Nice, Alpes-Maritimes, 06200, France

  • Hospital General de Tijuana ( Site 0284)

    Tijuana, Estado de Baja California, 22000, Mexico

  • Hospital Infantil Universitario Nino Jesus ( Site 0114)

    Madrid, 28009, Spain

  • Hospital Roberto del Río ( Site 0802)

    Santiago, Region M. de Santiago, 8380418, Chile

  • Hospital Universitario La Paz ( Site 0113)

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocio ( Site 0115)

    Seville, 41043, Spain

  • Hospital del Nino y Adolescente Morelense ( Site 0286)

    Emiliano Zapata, Morelos, 62765, Mexico

  • Instituto Nacional de Pediatria ( Site 0291)

    Mexico City, 04530, Mexico

  • Instytut Centrum Zdrowia Matki Polki ( Site 0223)

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0131)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014, Ukraine

  • Kharkiv City Children Hospital 16 ( Site 0130)

    Kharkiv, Kharkiv Oblast, 61075, Ukraine

  • MHAT City Clinic Sv. Georgi EOOD ( Site 0167)

    Montana, 3400, Bulgaria

  • MHAT Dr. Ival Seliminski ( Site 0173)

    Sliven, 8800, Bulgaria

  • Miller Children's & Women's Hospital ( Site 0349)

    Long Beach, California, 90806, United States

  • Molotlegi Street ( Site 0155)

    Pretoria, Gauteng, 0208, South Africa

  • Morozovskaya Children City Clinical Hospital ( Site 0241)

    Moscow, Moscow, 119049, Russia

  • Municipal Enterprise Children's City Clinical Hospital in Poltava City Council ( Site 0122)

    Poltava, Poltava Oblast, 36004, Ukraine

  • Pan and Aglaia Kyriakou Children s Hospital ( Site 0247)

    Athens, Attica, 11527, Greece

  • Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 0233)

    Moscow, Moscow, 117197, Russia

  • Philippine Children s Medical Center ( Site 0317)

    Quezon City, National Capital Region, 1104, Philippines

  • Rady Children's Hospital-San Diego ( Site 0347)

    San Diego, California, 92123, United States

  • Rambam Medical Center ( Site 0189)

    Haifa, 3109601, Israel

  • Regional Childrens Clinical Hospital ( Site 0400)

    Vologda, Vologda Oblast, 160022, Russia

  • SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 0198)

    Istanbul, 34453, Turkey (Türkiye)

  • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0121)

    Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine

  • SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0226)

    Łomianki, Masovian Voivodeship, 05-092, Poland

  • Schneider Children's Medical Center ( Site 0187)

    Petah Tikva, 4920235, Israel

  • Smolensk Regional Clinical Hospital ( Site 0231)

    Smolensk, Smolensk Oblast, 214018, Russia

  • Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0265)

    Bogotá, Bogota D.C., 11001000, Colombia

  • St.Petersburg State Pediatric Medical University ( Site 0236)

    Saint Petersburg, Sankt-Peterburg, 194100, Russia

  • State Budgetary Healthcare Institution of Novosibirsk Region City Childrens Clinical Emergency Hospi

    Novosibirsk, Novosibirsk Oblast, 630011, Russia

  • Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0105)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

  • Tallinn Children Hospital ( Site 0209)

    Tallinn, Harju, 13419, Estonia

  • Tufts Medical Center-Floating Hospital for Children ( Site 0350)

    Boston, Massachusetts, 02111, United States

  • UMHAT Deva Maria. EOOD ( Site 0165)

    Burgas, 8127, Bulgaria

  • UMHAT Dr. Georgi Stranski EAD ( Site 0174)

    Pleven, 5800, Bulgaria

  • UMHAT Kanev AD ( Site 0168)

    Rousse, 7002, Bulgaria

  • UMHAT Kanev AD ( Site 0169)

    Rousse, 7002, Bulgaria

  • University Hospital ( Site 0360)

    San Antonio, Texas, 78229, United States

  • University of Athens - Aghia Sophia Childrens Hospital ( Site 0243)

    Athens, Attica, 115 27, Greece

  • University of New Mexico ( Site 0358)

    Albuquerque, New Mexico, 87106, United States

  • University of the Philippines-Philippine General Hospital ( Site 0318)

    Manila, National Capital Region, 1000, Philippines

  • West Virginia University Ruby Memorial Hospital ( Site 0344)

    Morgantown, West Virginia, 26506, United States

  • Wojewodzki Szpital Zespolony im. Rydgiera ( Site 0220)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland