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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00050401 |
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.
Condition | Intervention | Phase |
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Pneumonia |
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 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-Associated Pneumonia |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Phoenix, Arizona, United States | |
United States, Delaware | |
Newark, Delaware, United States | |
United States, Indiana | |
Indianapolis, Indiana, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, New Hampshire | |
Lebanon, New Hampshire, United States | |
United States, New York | |
Albany, New York, United States | |
New York, New York, United States | |
Stony Brook, New York, United States | |
United States, Ohio | |
Cincinnati, Ohio, United States | |
United States, Texas | |
San Antonio, Texas, United States |
Study ID Numbers: | 3591IL/0082 |
Study First Received: | December 8, 2002 |
Last Updated: | June 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00050401 |
Health Authority: | United States: Food and Drug Administration |
ventilator-associated nosocomial |
Tobramycin Respiratory Tract Infections Respiratory Tract Diseases Meropenem Lung Diseases |
Vancomycin Aggression Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Infection Pharmacologic Actions |