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Bacterial InfectionsPhase 1TANGOKIDSNCT02687906

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

A Phase 1 study testing Vabomere in people with Bacterial Infections, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Bacterial Infections
What is being tested?
Vabomere
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
9 sitesUnited States
Study dates
Jul 2016to 15 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 32Show fewer
  • Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
  • 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;
  • 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);
  • 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.
  • Treatment within 30 days prior to enrollment with valproic acid;
  • Treatment within 30 days prior to enrollment with probenecid;
  • Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy;
  • Neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3;
  • Aspartate aminotransferase or alanine aminotransferase ≥ 3X ULN or total bilirubin ≥ 1.5X ULN;
  • Receipt of any investigational medication or investigational device within 30 days prior to enrollment;
  • Prior exposure to vaborbactam or Vabomere;
  • Use of meropenem within 48 hours of administration of study drug or 12 hours after study drug administration;
  • Known significant hypersensitivity to any beta-lactam antibiotic;
  • Unable or unwilling in the judgment of the Investigator, to comply with the protocol;
  • 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;
  • 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.)

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

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

    Chicago, Illinois, 60614

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Rutger's University

    New Brunswick, New Jersey, 08901

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Rady Children's Hospital San Diego

    San Deigo, California, 92123

  • Toledo Children's Hospital

    Toledo, Ohio, 43606

Other trials in United States

About this study

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

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

Read the detailed description

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 suspected or confirmed bacterial infection receiving antibiotic therapy or subjects receiving peri-operative prophylactic use of antibiotics.

Being tested
Vabomere
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VabomereDrug

    Also called Combination meropenem and vaborbactam, carbapenem and beta-lactamase inhibitor

    Vabomere (meropenem-vaborbactam) for IV injection

Study groups in NCT02687906
Study groupRoleWhat they receive
Single dose IV meropenem-vaborbactamExperimentalVabomere (meropenem-vaborbactam) for IV injection will be administered as a single dose diluted in normal saline infused IV over 3 hours * Cohort 1 (n=8): 12 to < 18 years of age (40 mg/kg) * Cohort 2 (n=8): 6 to < 12 years of age (40 mg/kg) * Cohort 2b (n=4): 6 to < 12 years of age (60 mg/kg) * Cohort 3 (n=8): 2 to < 6 years of age (60 mg/kg) * Cohort 4 (n=8): 3 months to < 2 years of age (60 mg/kg) * Cohort 5 (n=24): Birth to < 3 months of age (dose TBD) * Group A: Gestational Age (GA) < 32 weeks, Postnatal Age (PNA) < 2 weeks (n=6) * Group B: GA < 32 weeks, PNA > 2 weeks (n=6) * Group C: GA > 32 weeks, PNA < 2 weeks (n=6) * Group D: GA > 32 weeks, PNA > 2 weeks (n=6) * Cohort 6 (n=7): 2 to < 12 years of age and ≤ 35 kg of weight (80 mg/kg)
Receives: Drug: Vabomere

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics: AUC0-∞

    AUC from time zero to infinity

    Measured: From pre-dose until 6 hours after the start of the infusion

  2. Pharmacokinetics: Cmax

    maximum measured plasma concentration

    Measured: From pre-dose until 6 hours after the start of the infusion

  3. Pharmacokinetics: time to maximum plasma concentration (Tmax)

    time to Cmax

    Measured: From pre-dose until 6 hours after the start of the infusion

  4. Pharmacokinetics: drug clearance (CL)

    total body clearance

    Measured: From pre-dose until 6 hours after the start of the infusion

  5. Pharmacokinetics: t1/2

    elimination half- life

    Measured: From pre-dose until 6 hours after the start of the infusion

  6. Pharmacokinetics: Cmin

    minimum plasma concentration

    Measured: From pre-dose until 6 hours after the start of the infusion

  7. Pharmacokinetics: Vss

    Volume of distribution

    Measured: From pre-dose until 6 hours after the start of the infusion

  8. Safety and tolerability: AEs/SAEs

    a composite measure of the number and types of AEs/SAEs encountered and relationship to time of dosing

    Measured: From assent / consent until day 7 safety follow up call

  9. Safety and tolerability: clinical safety laboratory results

    A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline

    Measured: From assent / consent until day 7 safety follow up call

  10. Safety and tolerability: vital signs

    A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline

    Measured: From assent / consent until day 7 safety follow up call

  11. Safety and tolerability: ECGs

    A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline

    Measured: From assent / consent until day 7 safety follow up call

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJul 2026
  4. Study completion15 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02687906
Sponsor's protocol ID
Rempex 507
Other IDs
2016-000656-99, 2016
Acronym
TANGOKIDS
Status last verified
Aug 2026
First submitted
17 Feb 2016
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bradley JS, Harvey H, Stout D, Momper J, Capparelli E, Avedissian SN, Barbato C, Mak RH, Jones TP, Jones D, Le J. Subtherapeutic Meropenem Antibiotic Exposure in Children With Septic Shock Assessed by Noncompartmental Pharmacokinetic Analysis in a Prospective Dataset. Pediatr Crit Care Med. 2025 Apr 1;26(4):e507-e515. doi: 10.1097/PCC.0000000000003698. Epub 2025 Feb 18.

    PubMed 39964222

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vabomere in people with Bacterial Infections, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: AUC0-∞ (time frame: From pre-dose until 6 hours after the start of the infusion). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02687906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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