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

Phase 1

• Conditions: Suspected or confirmed negative bacterial infection; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: HLTClassification code 10004047Term: Bacterial infections NECSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10018657Term: Gram-negative bacterial infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-000656-99-Outside-EU/EEA
• Lead Sponsor: Rempex Pharmaceuticals-Melinta Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-28
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. A signed and dated written informed consent (ICF) 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 67
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Signs of severe sepsis;
2. 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;
3. 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;
4. Female adolescent subjects who are pregnant or breastfeeding or have a positive serum ß-human chorionic gonadotropin (hCG) pregnancy test at screening and at pre-dose Day 1;
5. Males who are unwilling to practice abstinence or use an acceptablemmethod of birth control during the entire study period (i.e. condom with spermicide);
6. Renal function at screening as estimated by creatinine clearance < 50 mL/min/1.73 m2 as calculated using the updated Schwartz bedside formula;
7. Treatment within 30 days prior to enrollment with valproic acid;
8. Treatment within 30 days prior to enrollment with probenecid;
9. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy;
10. Neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3;
11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3X ULN or total bilirubin = 1.5X ULN;
12. Receipt of any investigational medication or investigational device within 30 days prior to enrollment;
13. Previous exposure to vaborbactam or Vabomere;
14. Use of meropenem within 48 hours of administration of study drug or 12 hours after study drug
administration;
15. Known significant hypersensitivity to any beta-lactam antibiotic;
16. Unable or unwilling in the judgment of the Investigator, to comply with the protocol;
17. Subject is a child of 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;
18. Body mass index (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified