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

Launched by REMPEX (A WHOLLY OWNED SUBSIDIARY OF MELINTA THERAPEUTICS, LLC) · Feb 17, 2016

Keywords

ClinConnect Summary

This clinical trial is testing a medication called Vabomere (meropenem-vaborbactam) to find the right dose and check its safety in children and teenagers under 18 years old who have serious bacterial infections. The study is open to patients from birth to less than 18 years of age who are hospitalized and receiving antibiotics for a known or suspected bacterial infection. To join, a parent or legal guardian must give consent, and the child must be in stable condition and have the ability to receive the study medication through an intravenous line.

Participants in this trial can expect to receive a single dose of Vabomere while being closely monitored in the hospital for at least six hours after the medication is given. The study will help researchers understand how well the drug works and how it is processed in young patients. It’s important to note that certain medical conditions and treatments may prevent someone from participating, so a thorough evaluation will be done to ensure safety. Overall, this trial aims to improve treatment options for children with serious bacterial infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 exclusion criteria apply prior to randomization:
• 1. Signs of severe sepsis including:
• • 1. Shock or profound hypotension that is not responsive to fluid challenge;
• • 2. Hypothermia (core temperature \< 35.6 ºC or 96.1 ºF);
• • 3. Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time ≥ 2X the ULN or platelets \< 50% of the lower limit of normal;
• • 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 β-hCG pregnancy test at screening and at pre-dose Day 1;
• • 5. 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);
• • 6. 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.
• • 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 or alanine aminotransferase ≥ 3X ULN or total bilirubin ≥ 1.5X ULN;
• • 12. Receipt of any investigational medication or investigational device within 30 days prior to enrollment;
• • 13. Prior 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.)