Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00050401 |
Recruitment Status :
Completed
First Posted : December 10, 2002
Last Update Posted : September 1, 2017
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Condition or disease | Intervention/treatment | 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 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 500 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia |
Study Start Date : | July 2002 |
Actual Primary Completion Date : | September 2004 |
Actual Study Completion Date : | September 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
- Diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support
- Patient or Patient's legal guardian must sign written informed consent for study participation, pretreatment, and Day 7 bronchoscopy
Exclusion Criteria:
- Patients with hospital-acquired pneumonia caused by pathogens resistant to MERREM
- Patients with allergies to cephalosporins, penicillins and carbapenems
- Patients taking anticonvulsant therapy for a known seizure disorder
- Patients with lung cancer
- Patients with cystic fibrosis, acquired immune deficiency syndrome (AIDS), neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in preparation for or following an organ transplant.
- Patients who are pregnant or breast feeding
- Patients who are unlikely to survive
- Patients with certain infections in another area requiring treatment with additional antibiotics
- Patients with other underlying conditions that would make it difficult to interpret response to study drug.
- Patients who have been part of another clinical study 30 days before entry into this study.
- Patients with hypotension (systolic BP < 85mmHg) or acidosis (arterial pH <7.25 or serum bicarbonate <15 mg/dl) despite attempts at fluid resuscitation
- Patients with profound hypoxia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050401
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 |
ClinicalTrials.gov Identifier: | NCT00050401 |
Other Study ID Numbers: |
3591IL/0082 |
First Posted: | December 10, 2002 Key Record Dates |
Last Update Posted: | September 1, 2017 |
Last Verified: | August 2017 |
ventilator-associated nosocomial |
Pneumonia, Ventilator-Associated Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection |
Infection Vancomycin Tobramycin Meropenem Anti-Bacterial Agents Anti-Infective Agents |