Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

Phase 4

Completed

• Conditions: Pneumonia, Ventilator-Associated
• Interventions: Drug: Linezolid; Drug: Vancomycin

• Registration Number: NCT00572559
• Lead Sponsor: Pfizer

Brief Summary

Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2005-01
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-13
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-08
• Last Update Posted: 2010-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• The patient must have or be suspected of having a ventilator-associated pneumonia (VAP) due to MRSA.
• Patient must be hospitalized for at least 5 days, must be ventilator-dependent ≥ 48 hours prior to screen/baseline, and anticipated to remain on the ventilator for 72 hours after enrollment so follow-up BAL can be performed.
• Clinical picture compatible with pneumonia (acquired during ventilation)
• Chest X Ray at baseline/screen or within 24 hours of initiation of therapy must be consistent with diagnosis of pneumonia

Exclusion Criteria

• Hypersensitivity to linezolid, vancomycin, or one of the excipients in any of these drug formulations.
• Infections due to gram-positive organisms known to be resistant to either of the study drugs.
• Any antibiotic used in the treatment of MRSA, such as vancomycin, TMP/SMX, rifampin, or linezolid, for more than 48 hours prior to patient's enrollment into the study.
• Patients with neutropenia, AIDS, lymphoma or anticipated chemotherapy.
• Patients who have long-term tracheostomy (for more than 60 days). Acute tracheostomy patients are allowed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Linezolid	-
1	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin.	72-96 hours

Secondary Outcome Measures

Name	Time	Method
To compare duration of mechanical ventilation	0000
To compare post treatment tracheal colonization	FU: 14 days after EOT +/- 2 days
To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)	EOT: Day 14; FU: 14 days after EOT +/- 2 days
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure	72-96 hours
To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU	EOT: Day 14; FU: 14 days after EOT +/- 2 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 San Juan, Puerto Rico