Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infec… (NCT02687906) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
United States39 participantsStarted 2016-07
Plain-language summary
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
Who can participate
Age range17 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Pharmacokinetics: AUC0-∞
Timeframe: From pre-dose until 6 hours after the start of the infusion
2
Pharmacokinetics: Cmax
Timeframe: From pre-dose until 6 hours after the start of the infusion
3
Pharmacokinetics: time to maximum plasma concentration (Tmax)
Timeframe: From pre-dose until 6 hours after the start of the infusion
4
Pharmacokinetics: drug clearance (CL)
Timeframe: From pre-dose until 6 hours after the start of the infusion
5
Pharmacokinetics: t1/2
Timeframe: From pre-dose until 6 hours after the start of the infusion
6
Pharmacokinetics: Cmin
Timeframe: From pre-dose until 6 hours after the start of the infusion
7
Pharmacokinetics: Vss
Timeframe: From pre-dose until 6 hours after the start of the infusion
8
Safety and tolerability: AEs/SAEs
Timeframe: From assent / consent until day 7 safety follow up call
Trial details
NCT IDNCT02687906
SponsorRempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
✕. 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);
9
Safety and tolerability: clinical safety laboratory results
Timeframe: From assent / consent until day 7 safety follow up call
10
Safety and tolerability: vital signs
Timeframe: From assent / consent until day 7 safety follow up call
11
Safety and tolerability: ECGs
Timeframe: From assent / consent until day 7 safety follow up call