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NCT00307099 · ClinicalTrials.gov registry record · Phase 3
Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
NCT00307099 is a Phase 3 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 460 participants.
The verdict
NCT00307099, a Phase 3 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
Study Summary
This study will enroll 460 subjects who have new pulmonary infiltrates during their ICU stay and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic treatment with meropenem (with or without coverage for MRSA) for ICU subjects diagnosed with new pulmonary infiltrates can reduce the emergence of anti-microbial-resistant organisms and the isolation of a potential pathogen compared to a standard course of antibiotic therapy (minimum of 8 days of therapy with antibiotics of the primary care team's choosing). Subjects will be randomly placed in either the meropenem group or standard antibiotic therapy group. The study will also examine whether short-course therapy reduces hospital length of stay and hospital cost, without having a negative effect on subject morbidity and mortality.
Interventions
- DRUG Meropenem
- DRUG Standard antibiotic therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00307099
The ClinicalTrials.gov registry entry for NCT00307099 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Meropenem is the first listed.
NCT00307099 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00307099 about?
NCT00307099 is a clinical study titled "Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU". This study will enroll 460 subjects who have new pulmonary infiltrates during their ICU stay and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic treatment with meropenem (with ...
What is the current status of trial NCT00307099?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2006-10. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00307099?
The interventions under investigation include: Meropenem (DRUG), Standard antibiotic therapy (DRUG).
Who is sponsoring clinical trial NCT00307099?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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