Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

Febrile Neutropenia Clinical Trial

Official title:

A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035425
• Other study ID #: M12600079
• Secondary ID: A5951059
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2002
• Last updated: November 30, 2009
• Start date: November 2001
• Est. completion date: November 2002

Study information

• Verified date: November 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).

Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections.

Exclusion Criteria:

Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial.

Patients with endocarditis, osteomyelitis, meningitis, CNS infections.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• linezolid
600mg every 12 hours
• vancomycin
1gm every 12 hours. The dose of vancomycin intravenously may be adjusted for renal function, but the patient must be able to receive a 300 mL volume of intravenous fluid at the assigned dosing times of every 12 hours.

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Cordoba
Argentina	Pfizer Investigational Site	Mendoza
Argentina	Pfizer Investigational Site	Unknown	Córdoba
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo
Brazil	Pfizer Investigational Site	São Paulo
Chile	Pfizer Investigational Site	Santiago
Colombia	Pfizer Investigational Site	Bogota	Bogota. DC
Colombia	Pfizer Investigational Site	Bogota	Bogota. DC
Colombia	Pfizer Investigational Site	Medellin
Finland	Pfizer Investigational Site	Helsinki
Mexico	Pfizer Investigational Site	Mexico D.f.
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Mexico	Pfizer Investigational Site	Zapopan	Jalisco
Pakistan	Pfizer Investigational Site	Karachi
Pakistan	Pfizer Investigational Site	Lahore	Punjab
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Federal Way	Washington
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Lakewood	Washington
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Tacoma	Washington
Venezuela	Pfizer Investigational Site	Caracas	Distrito Federal
Venezuela	Pfizer Investigational Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Brazil,  Chile,  Colombia,  Finland,  Mexico,  Pakistan,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.		7-28 days	No
Secondary	Microbiologic outcome		7-28 days	No
Secondary	Pathogen eradication (eradication rates of individual pathogens)		7-28 days	No
Secondary	Defervescence (defined as Tmax orally or rectally)		7-28 days	No
Secondary	Time to defervescence		7-28 days
Secondary	Resolution of neutropenia (return of ANC to >500 cells/mm3)		7-28 days	No
Secondary	Time to resolution of neutropenia		7-28 days	No
Secondary	Mortality rate (survival at 7 days after the end of therapy)		7-28 days	No

External Links

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