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Completed

NCT Number: NCT00572559

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

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.

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Key information

Conditions

Pneumonia, Ventilator-Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vancomycin

Drug

1 gram IV every 12 hours for 7 to 14 days

Linezolid

Drug

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

Primary outcomes

  1. 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.

    Time frame: 72-96 hours

Secondary outcomes

  1. To compare duration of mechanical ventilation

    Time frame: 0000

  2. To compare post treatment tracheal colonization

    Time frame: FU: 14 days after EOT +/- 2 days

  3. To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)

    Time frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days

  4. To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure

    Time frame: 72-96 hours

  5. To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU

    Time frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Study completion
2005
First posted
Dec 13, 2007
Registry last updated
Jun 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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