Summary

Eligibility
for people ages up to 17 years (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jaime Deville, MD (ucla)

Description

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

Official Title

An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years of Age With Serious Bacterial Infections

Details

In the current era of increased resistance to extended spectrum cephalosporins, carbapenem antimicrobial agents are frequently the antibiotics of "last defense" for the most resistant pathogens in serious infections, including those found in complicated Urinary Tract Infections (cUTI). The recent dissemination of serine carbapenemases (e.g. KPC) in Enterobacteriaceae in many hospitals worldwide now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents. Rempex developed meropenem-vaborbactam administered as a fixed combination by IV infusion, to treat serious Gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems. This study is an open label, dose-finding, pharmacokinetics, safety, and tolerability study of a single dose infusion of meropenem-vaborbactam in pediatric subjects from birth to less than 18 years of age with serious bacterial infections

Keywords

Bacterial Infections Infections Communicable Diseases Meropenem Vaborbactam beta-Lactamase Inhibitors Vabomere Single dose IV meropenem-vaborbactam

Eligibility

You can join if…

Open to people ages up to 17 years

  1. A signed and dated written informed consent from the parent or legal representative and a subject assent (according to local IRB requirements);
  2. Male or female from birth to < 18 years of age;
  3. 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;
  4. The subject will be observed in the hospital for at least 6 hours after the study drug is administered;
  5. 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;
  6. Sufficient intravascular access (peripheral or central) to receive study drug.

Subjects will be excluded from the study if any of the following

You CAN'T join if...

apply prior to randomization:

  1. Signs of severe sepsis including:
  2. Shock or profound hypotension that is not responsive to fluid challenge;
  3. Hypothermia (core temperature < 35.6 ºC or 96.1 ºF);
  4. Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time ≥ 2X the ULN or platelets < 50% of the lower limit of normal;
  5. 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;
  6. 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;
  7. 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;
  8. 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. Renal function at screening as estimated by creatinine clearance < 50 mL/min using the Cockcroft-Gault formula;
  10. Treatment within 30 days prior to enrollment with valproic acid;
  11. Treatment within 30 days prior to enrollment with probenecid;
  12. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy;
  13. . Neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3;
  14. . Aspartate aminotransferase or alanine aminotransferase ≥ 3X ULN or total bilirubin ≥ 1.5X ULN;
  15. . Receipt of any investigational medication or investigational device within 30 days prior to enrollment;
  16. . Prior exposure to vaborbactam or Vabomere;
  17. . Use of meropenem within 48 hours of administration of study drug or 12 hours after study drug administration;
  18. . Known significant hypersensitivity to any beta-lactam antibiotic;
  19. . Unable or unwilling in the judgment of the Investigator, to comply with the protocol;
  20. . An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator;
  21. . BMI outside the range (below the 5th percentile or above the 95th percentile) for height, age and weight except for children < 2 years of age.)

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Rady Children's Hospital San Diego accepting new patients
    San Diego California 92123 United States
  • Children's Hospital of Orange County in progress, not accepting new patients
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Jaime Deville, MD (ucla)
    HS Clinical Professor, Pediatrics. Authored (or co-authored) 19 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
ID
NCT02687906
Phase
Phase 1
Study Type
Interventional
Last Updated