Cost Effectiveness Of Linezolid In Central America

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040585
Recruitment Status : Withdrawn
First Posted : December 29, 2009
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):

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
Ventilator Acquired Pneumonia Drug: Linezolid

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

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult men and women with VAP.

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 identifier (NCT number): NCT01040585

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer 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
ventilator acquired pneumonia
central america

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action