Cost Effectiveness Of Linezolid In Central America

Ventilator Acquired Pneumonia Clinical Trial

Official title:

Cost Effectiveness Of Linezolid Vs Vancomycin In The Treatment Of Ventilator Acquired Pneumonia In Central America

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01040585
• Other study ID #: A5951154
• Status: Withdrawn
• Phase: Phase 4
• First received: December 24, 2009
• Last updated: March 1, 2012
• Start date: July 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Acquired Pneumonia

Intervention

Drug:
• Linezolid
Treatment for VAP as indication approved and as physician criterium.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of resistance Empirical treatment days before specific therapy. Treatment days with Linezolid. Treatment days with Vancomycin.		4 months	No
Primary	Rate of renal failure.		4 months	No
Primary	Rate of healing with Linezolid.		4 months	No
Primary	Rate of healing with Vancomycin.		4 months	No
Secondary	Hospitalization days average with VAN and Linezolid.		4 months	No
Secondary	Variation of prices and values among the different institutions.		4 months	No
Secondary	The average costs of each intervention.		4 months	No

External Links

•   To obtain contact information for a study center near you, click here.