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NCT03969901 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
NCT03969901 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 115 participants.
The verdict
NCT03969901, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.
Interventions
- DRUG Active Control
- DRUG IMI/REL
- DRUG Oral Switch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03969901
The ClinicalTrials.gov registry entry for NCT03969901 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Active Control is the first listed.
NCT03969901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03969901 about?
NCT03969901 is a clinical study titled "Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)". The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through...
What is the current status of trial NCT03969901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2019-10-08. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT03969901?
The interventions under investigation include: Active Control (DRUG), IMI/REL (DRUG), Oral Switch (DRUG).
Who is sponsoring clinical trial NCT03969901?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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