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NCT00572559 Clinical Trial

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

Pneumonia, Ventilator-Associated Clinical Trial

Official title:
A Randomized, Open Label, Multi-Center Clinical Trial, Comparing Microbiologic Response To Linezolid And Vancomycin In Ventilator-Associated Pneumonia (VAP) Due To Methicillin Resistant Staphylococcus Aureus (MRSA)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00572559
Other study ID # 766-INF-0026-126
Secondary ID A5951069
Status Completed
Phase Phase 4
First received December 11, 2007
Last updated June 8, 2010
Start date November 2002
Est. completion date January 2005

Study information
Verified date June 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 149
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vancomycin
1 gram IV every 12 hours for 7 to 14 days
• Linezolid
600 mg every 12 hours (intravenously [IV] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days

Locations
Country Name City State
Puerto Rico Pfizer Investigational Site San Juan
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Bronx New York
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cortland Manor New York
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Ewa Beach Hawaii
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jamaica New York
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Morgantown West Virginia
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site North East Atlanta Georgia
United States Pfizer Investigational Site North East Atlanta Georgia
United States Pfizer Investigational Site North East Atlanta Georgia
United States Pfizer Investigational Site Norwalk Connecticut
United States Pfizer Investigational Site Palm Springs California
United States Pfizer Investigational Site Peoria Illinois
United States Pfizer Investigational Site Peoria Illinois
United States Pfizer Investigational Site Peoria Illinois
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Rancho Mirage California
United States Pfizer Investigational Site Redlands California
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Waterbury Connecticut
United States Pfizer Investigational Site Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary To compare duration of mechanical ventilation 0000 No
Secondary To compare post treatment tracheal colonization FU: 14 days after EOT +/- 2 days No
Secondary 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 No
Secondary To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure 72-96 hours No
Secondary 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 No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06370598 - Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia Phase 1/Phase 2
Terminated NCT02806141 - Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates Phase 3
Completed NCT01765530 - Efficacy Study of a Novel Device to Clean the Endotracheal Tube N/A
Completed NCT00521677 - Comparison Between Two Methods of Oral Care on the Incidence of VAP N/A
Completed NCT00529776 - Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy N/A
Completed NCT03401463 - Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar N/A
Completed NCT02950519 - Endotracheal Tube Cuff Pressures in Ventilated Patients N/A
Completed NCT01875692 - Can we Better Understand the Development of VAP and Eventually Predict and Prevent it? N/A
Completed NCT00515034 - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia Phase 2
Recruiting NCT05117125 - Biomarkers for Ventilator-associated Pneumonia
Completed NCT04755972 - Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2 N/A
Terminated NCT02940626 - Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus. Phase 2
Completed NCT01577862 - Colistin and Rifampicin for MDR-Acinetobacter Phase 3
Withdrawn NCT04566172 - Preoperative Optimization to Improve Functional Status N/A
Recruiting NCT04215692 - Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients N/A
Completed NCT03816956 - Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 Phase 3
Active, not recruiting NCT01123681 - Intubation and Extubation Over 48 Hours Mechanical Ventilation N/A
Recruiting NCT04839653 - Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria N/A
Recruiting NCT03527992 - Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia N/A
Recruiting NCT05405491 - Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation N/A

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