Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00050401

Collaborator

(none)

500

Enrollment

Locations

26.1

Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Interventional

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 :

Jul 1, 2002

Actual Primary Completion Date :

Sep 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Newark	Delaware	United States
3	Indianapolis	Indiana	United States
4	Boston	Massachusetts	United States
5	Lebanon	New Hampshire	United States
6	Albany	New York	United States
7	New York	New York	United States
8	Stony Brook	New York	United States
9	Cincinnati	Ohio	United States
10	San Antonio	Texas	United States