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NCT00050401 · ClinicalTrials.gov registry record · Phase 3
Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
A Phase 3 study of Pneumonia, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 10
- Study locations
NCT00050401 is a Phase 3 study of Pneumonia that has completed, run by Pfizer. The registered enrollment target is 500 participants, below the 4,509-participant average among 47 other Pneumonia trials with a reported enrollment target (89% lower). The trial reports 10 study locations across 8 states.
The verdict
NCT00050401, a Phase 3 study of Pneumonia, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
Conditions Studied
Interventions
- DRUG MERREM I.V. 2g as a 3 hour infusion every 8 hours
- DRUG vancomycin I.V. 1 g every 12 hours
- DRUG tobramycin I.V. 5 mg/kg every 24 hours
- DRUG MERREM I.V. 1g as a 30 minute infusion every 8 hours
- DRUG MERREM I.V. 500 mg as a 3 hour infusion every 8 hours
Study Locations (10)
New York
- - Albany
- - New York
- - Stony Brook
Arizona
- - Phoenix
Delaware
- - Newark
Indiana
- - Indianapolis
Massachusetts
- - Boston
New Hampshire
- - Lebanon
Ohio
- - Cincinnati
Texas
- - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2002-07 |
| Est. Completion | 2004-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050401
The ClinicalTrials.gov registry entry for NCT00050401 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,509-participant average among 47 other Pneumonia trials with a reported enrollment target (89% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pneumonia appearing as the primary indexed condition, and to 5 interventions - of which MERREM I.V. 2g as a 3 hour infusion every 8 hours is the first listed.
NCT00050401 reports 10 study locations spanning 8 distinct geographic areas - top geographies include New York, Arizona, Delaware.
Frequently Asked Questions
What is clinical trial NCT00050401 about?
NCT00050401 is a clinical study titled "Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support". The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can c...
What is the current status of trial NCT00050401?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2002-07. Estimated completion is 2004-09.
What conditions does trial NCT00050401 study?
This clinical trial studies the following conditions: Pneumonia.
What interventions are being tested in trial NCT00050401?
The interventions under investigation include: MERREM I.V. 2g as a 3 hour infusion every 8 hours (DRUG), vancomycin I.V. 1 g every 12 hours (DRUG), tobramycin I.V. 5 mg/kg every 24 hours (DRUG), MERREM I.V. 1g as a 30 minute infusion every 8 hours (DRUG), MERREM I.V. 500 mg as a 3 hour infusion every 8 hours (DRUG).
Who is sponsoring clinical trial NCT00050401?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00050401 being conducted?
This trial has 10 study locations across Arizona, Delaware, Indiana, Massachusetts, New Hampshire. 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.