Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT01040585 |
Date of registration:
|
24/12/2009 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Cost Effectiveness Of Linezolid In Central America
|
Scientific title:
|
Cost Effectiveness Of Linezolid Vs Vancomycin In The Treatment Of Ventilator Acquired Pneumonia In Central America |
Date of first enrolment:
|
July 2010 |
Target sample size:
|
0 |
Recruitment status: |
Withdrawn |
URL:
|
http://clinicaltrials.gov/show/NCT01040585 |
Study type:
|
Observational |
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
Phase:
|
|
|
Countries of recruitment
|
El Salvador
|
Honduras
|
Nicaragua
| | | | | |
Contacts
|
Name:
|
Pfizer CT.gov Call Center |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Pfizer |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Evidence of a legally acceptable representative signed and dated informed consent
document indicating that him or her has been informed of all pertinent aspects of the
study.
- Adult (18 years old or older) men and women with confirm diagnosis of VAP treated on
ICU with LIN or VAN; on the selected institutions.
Exclusion Criteria:
- Adult men or women with nosocomial pneumonia not associated to a ventilator.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Ventilator Acquired Pneumonia
|
Intervention(s)
|
Drug: Linezolid
|
Primary Outcome(s)
|
Rate of renal failure.
[Time Frame: 4 months]
|
Rate of healing with Linezolid.
[Time Frame: 4 months]
|
Rate of healing with Vancomycin.
[Time Frame: 4 months]
|
The rate of resistance Empirical treatment days before specific therapy. Treatment days with Linezolid. Treatment days with Vancomycin.
[Time Frame: 4 months]
|
Secondary Outcome(s)
|
Hospitalization days average with VAN and Linezolid.
[Time Frame: 4 months]
|
The average costs of each intervention.
[Time Frame: 4 months]
|
Variation of prices and values among the different institutions.
[Time Frame: 4 months]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|