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NCT02687906 · ClinicalTrials.gov registry record · Phase 1
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
A Phase 1 study of Bacterial Infections, sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC).
- Active
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 9
- Study locations
NCT02687906 is a Phase 1 study of Bacterial Infections that is active but no longer recruiting, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC). The registered enrollment target is 39 participants, below the 139-participant average among 17 other Bacterial Infections trials with a reported enrollment target (72% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT02687906, a Phase 1 study of Bacterial Infections, is active but no longer recruiting, sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 9
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Vabomere
Study Locations (9)
California
- Ronald Reagan UCLA Medical Center - Los Angeles
- Children's Hospital of Orange County - Orange
- Rady Children's Hospital San Diego - San Diego
Ohio
- Rainbow Babies and Childrens Hospital - Cleveland
- Toledo Children's Hospital - Toledo
Arkansas
- Arkansas Children's Hospital - Little Rock
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Nebraska
- University of Nebraska Medical Center - Omaha
New Jersey
- Rutger's University - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2016-07 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02687906
The ClinicalTrials.gov registry entry for NCT02687906 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 17 other Bacterial Infections trials with a reported enrollment target (72% lower). The listed sponsor is Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC), which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bacterial Infections appearing as the primary indexed condition, and to 1 intervention - of which Vabomere is the first listed.
NCT02687906 reports 9 study locations spanning 6 distinct geographic areas - top geographies include California, Ohio, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02687906 about?
NCT02687906 is a clinical study titled "Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With 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
What is the current status of trial NCT02687906?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2016-07. Estimated completion is 2025-12.
What conditions does trial NCT02687906 study?
This clinical trial studies the following conditions: Bacterial Infections.
What interventions are being tested in trial NCT02687906?
The interventions under investigation include: Vabomere (DRUG).
Who is sponsoring clinical trial NCT02687906?
This trial is sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02687906 being conducted?
This trial has 9 study locations across Arkansas, California, Illinois, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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