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Cost Effectiveness Of Linezolid In Central America

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: December 24, 2009
Last updated: March 1, 2012
Last verified: March 2012
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 ]
  • 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 ]

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

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.


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01040585

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01040585     History of Changes
Other Study ID Numbers: A5951154
Study First Received: December 24, 2009
Last Updated: March 1, 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 processed this record on August 18, 2017