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NCT01597973 · ClinicalTrials.gov registry record · Phase 3
Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)
A Phase 3 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
NCT01597973 is a Phase 3 study that has completed, run by University of Michigan. The registered enrollment target is 467 participants.
The verdict
NCT01597973, a Phase 3 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
Study Summary
Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterobacter spp. and/or Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both BSI and pneumonia at the time of study enrollment, they will be included as a subject with pneumonia. Objectives: Primary: •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to XDR-GNB. Secondary: •Determine what treatment regimen (colistin monotherapy or colistin combined with a carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy.
Interventions
- DRUG colistin and meropenem
- DRUG colistin and placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2012-10-06 |
| Est. Completion | 2020-08-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01597973
The ClinicalTrials.gov registry entry for NCT01597973 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 467 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which colistin and meropenem is the first listed.
NCT01597973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01597973 about?
NCT01597973 is a clinical study titled "Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)". Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of...
What is the current status of trial NCT01597973?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2012-10-06. Estimated completion is 2020-08-09.
What interventions are being tested in trial NCT01597973?
The interventions under investigation include: colistin and meropenem (DRUG), colistin and placebo (DRUG).
Who is sponsoring clinical trial NCT01597973?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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