Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections

Running, not enrolling · Phase 1

Conditions studied: Bacterial Infections

In brief

A single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18 years of age with serious bacterial infections

Key facts

Study ID

NCT02687906

Run by

Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)

People needed

39

Starts

2016-07-01

Expected to finish

2026-12-01

Last updated by the study team

2026-06-04

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A signed and dated written informed consent from the parent or legal representative and a subject assent (according to local IRB requirements);
• Male or female from birth to < 18 years of age;
• Are hospitalized, in stable condition, and receiving systemic antibiotics for a known or suspected bacterial infection; or subjects receiving peri-operative prophylactic use of antibiotics;
• The subject will be observed in the hospital for at least 6 hours after the study drug is administered;
• If female and has reached menarche, or has reached Tanner Stage 3 breast development (even if not having reached menarche), the subject is practicing appropriate birth control or is sexually abstinent;
• Sufficient intravascular access (peripheral or central) to receive study drug.
• Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
• Signs of severe sepsis including:
• Shock or profound hypotension that is not responsive to fluid challenge;
• Hypothermia (core temperature < 35.6 ºC or 96.1 ºF);
• Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time ≥ 2X the ULN or platelets < 50% of the lower limit of normal;
• Any surgical or medical condition which, in the opinion of the investigator, would put the subject at increased risk or is likely to interfere with study procedures or PK of the study drug;
• Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant) during the entire study period;
• Female adolescent subjects who are pregnant or breastfeeding or have a positive serum β-hCG pregnancy test at screening and at pre-dose Day 1;
• Males who are unwilling to practice abstinence or use an acceptable method of broth control during the entire study period (i.e. condom with spermicide);
• Renal function at screening as estimated by creatinine clearance < 50 mL/min /1.73 m\^2 as calculated using the updated Schwartz bedside formula: eGFR = k x (height in cm) ÷ serum creatinine
• k = 0.33 in pre-term infants.
• k = 0.45 in term infants to 1 year of age.
• k = 0.55 in children and adolescent girls.
• k = 0.70 in adolescent boys.
• Treatment within 30 days prior to enrollment with valproic acid;
• Treatment within 30 days prior to enrollment with probenecid;
• Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy;
• Neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3;
• Aspartate aminotransferase or alanine aminotransferase ≥ 3X ULN or total bilirubin ≥ 1.5X ULN;

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Rutger's University — New Brunswick, New Jersey, United States
• Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
• Toledo Children's Hospital — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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