Back to resultsMicrobiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
Primary Purpose
Pneumonia, Ventilator-Associated
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vancomycin
Linezolid
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Ventilator-Associated
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To compare duration of mechanical ventilation
To compare post treatment tracheal colonization
To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure
To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00572559
Brief Title
Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
1 gram IV every 12 hours for 7 to 14 days
Intervention Type
Drug
Intervention Name(s)
Linezolid
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To compare duration of mechanical ventilation
Time Frame
0000
Title
To compare post treatment tracheal colonization
Time Frame
FU: 14 days after EOT +/- 2 days
Title
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
Title
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure
Time Frame
72-96 hours
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Pfizer Investigational Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Pfizer Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95829
Country
United States
Facility Name
Pfizer Investigational Site
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06721
Country
United States
Facility Name
Pfizer Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Pfizer Investigational Site
City
North East Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Pfizer Investigational Site
City
North East Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Pfizer Investigational Site
City
North East Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Pfizer Investigational Site
City
Ewa Beach
State/Province
Hawaii
ZIP/Postal Code
96706
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Pfizer Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Pfizer Investigational Site
City
Cortland Manor
State/Province
New York
ZIP/Postal Code
10567
Country
United States
Facility Name
Pfizer Investigational Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-3375
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220
Country
United States
Facility Name
Pfizer Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Pfizer Investigational Site
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
18719064
Citation
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):1200-1207. doi: 10.1378/chest.08-0011. Epub 2008 Aug 21.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=766-INF-0026-126&StudyName=Microbiologic%20Response%20With%20Linezolid%20And%20Vancomycin%20In%20Ventilator-Associated%20Pneumonia%20Due%20To%20Methicillin%20Resistant%20Staphylococcus%20Aureus
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
We'll reach out to this number within 24 hrs