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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ventilator-Associated Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00572559
Pfizer
Completed
Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

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Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
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)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pneumonia, Ventilator-Associated
  • Drug: Vancomycin
    1 gram IV every 12 hours for 7 to 14 days
  • Drug: 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
  • Experimental: 1
    Intervention: Drug: Vancomycin
  • Experimental: 2
    Intervention: Drug: Linezolid
Wunderink RG, Mendelson MH, Somero MS, Fabian TC, May AK, Bhattacharyya H, Leeper KV Jr, Solomkin JS. Early microbiological response to linezolid vs vancomycin in ventilator-associated pneumonia due to methicillin-resistant Staphylococcus aureus. Chest. 2008 Dec;134(6):1200-7. doi: 10.1378/chest.08-0011. Epub 2008 Aug 21.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
January 2005
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00572559
766-INF-0026-126
A5951069
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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