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NCT04983901 · ClinicalTrials.gov registry record · Phase 2
Phase II Single-center, Randomized, Open-label, Prospective, Study TO Determine THE Impact OF Serial Procalcitonin
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT04983901: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT04983901 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04983901, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia). In this study, imipenem-relebactam will be compared to the standard-of-care treatment (cefepime, meropenem, or piperacillin/tazobactam) for the treatment of febrile neutropenia. Imipenem-relebactam is used to treat infections. Giving imipenem-relebactam may help to control febrile neutropenia in patients with cancer.
Primary Outcome
The primary efficacy outcome is favorable clinical response of the patients in the MITT (Modified Intent-To-Treat) Analysis Set at end of inpatient intravenous therapy (EOIV). The clinical outcome has three categories: Favorable clinical response, Clinical failure, and Indeterminate.
Interventions
- DRUG Vancomycin
- DRUG Cefepime
- DRUG Meropenem
- DRUG Imipenem/Cilastatin/Relebactam
- DRUG Piperacillin-Tazobactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2023-10-06 |
| Phase | Phase 2 |
What the finished NCT04983901 record still lists
NCT04983901 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which Vancomycin is the first listed.
NCT04983901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04983901 about?
NCT04983901 is a clinical study titled "Phase II Single-center, Randomized, Open-label, Prospective, Study TO Determine THE Impact OF Serial Procalcitonin". This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia). In this study, imipenem-relebactam will be compared to the standard-of-care treatment (cefepime, meropenem, or piperacillin/tazoba...
What is the current status of trial NCT04983901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2021-09-14. Estimated completion is 2023-10-06.
What interventions are being tested in trial NCT04983901?
The interventions under investigation include: Vancomycin (DRUG), Cefepime (DRUG), Meropenem (DRUG), Imipenem/Cilastatin/Relebactam (DRUG), Piperacillin-Tazobactam (DRUG).
Who is sponsoring clinical trial NCT04983901?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04983901's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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