Cost Effectiveness Of Linezolid In Central America
This study has been withdrawn prior to enrollment.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01040585
First received: December 24, 2009
Last updated: March 1, 2012
Last verified: March 2012
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Purpose
The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN) for the treatment of nosocomial Pneumonia associate to ventilator (VAP).
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilator Acquired Pneumonia |
Drug: Linezolid |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Cost Effectiveness Of Linezolid Vs Vancomycin In The Treatment Of Ventilator Acquired Pneumonia In Central America |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The rate of resistance Empirical treatment days before specific therapy. Treatment days with Linezolid. Treatment days with Vancomycin. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Rate of renal failure. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Rate of healing with Linezolid. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Rate of healing with Vancomycin. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hospitalization days average with VAN and Linezolid. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Variation of prices and values among the different institutions. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- The average costs of each intervention. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Central America and the Caribbean
Panama, Costa Rica, Honduras, El Salvador and Nicaragua
|
Drug: Linezolid
Treatment for VAP as indication approved and as physician criterium.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult men and women with VAP.
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01040585 History of Changes |
| Other Study ID Numbers: | A5951154 |
| Study First Received: | December 24, 2009 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pfizer:
|
cost effectiveness linezolid ventilator acquired pneumonia central america |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection Ventilator-Induced Lung Injury |
Lung Injury Linezolid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013