ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2016-07

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02687906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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. 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.)	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
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.)

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Study Director

STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Study Locations (Sites)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

Rady Children's Hospital San Diego

San Diego, California, 92123

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60614

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68114

United States

Rutger's University

New Brunswick, New Jersey, 08901

United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

United States

Toledo Children's Hospital

Toledo, Ohio, 43606

United States

Collaborators and Investigators

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

Study Director, STUDY_DIRECTOR, Melinta Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-07

Study Completion Date2025-12

Study Record Updates

Study Start Date2016-07

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Bacterial Infections