Cost Effectiveness Of Linezolid In Central America

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01040585
First received: December 24, 2009
Last updated: March 1, 2012
Last verified: March 2012
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040585

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  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 April 17, 2014