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Cost Effectiveness Of Linezolid In Central America

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ClinicalTrials.gov Identifier: NCT01040585
Recruitment Status : Withdrawn
First Posted : December 29, 2009
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN) for the treatment of nosocomial Pneumonia associate to ventilator (VAP).

Condition or disease Intervention/treatment Phase
Ventilator Acquired Pneumonia Drug: Linezolid Phase 4

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cost Effectiveness Of Linezolid Vs Vancomycin In The Treatment Of Ventilator Acquired Pneumonia In Central America
Study Start Date : July 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Linezolid
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. The rate of resistance Empirical treatment days before specific therapy. Treatment days with Linezolid. Treatment days with Vancomycin. [ Time Frame: 4 months ]
  2. Rate of renal failure. [ Time Frame: 4 months ]
  3. Rate of healing with Linezolid. [ Time Frame: 4 months ]
  4. Rate of healing with Vancomycin. [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Hospitalization days average with VAN and Linezolid. [ Time Frame: 4 months ]
  2. Variation of prices and values among the different institutions. [ Time Frame: 4 months ]
  3. The average costs of each intervention. [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040585


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01040585     History of Changes
Other Study ID Numbers: A5951154
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012

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-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action