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

Phase 3

Completed

• Conditions: Febrile Neutropenia
• Interventions: Drug: linezolid; Drug: vancomycin

• Registration Number: NCT00035425
• Lead Sponsor: Pfizer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2002-05-03
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Study Completion: 2002-11
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-30
• Last Update Posted: 2009-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A.	linezolid	Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days.
B.	vancomycin	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Time to defervescence	7-28 days
Time to resolution of neutropenia	7-28 days
Mortality rate (survival at 7 days after the end of therapy)	7-28 days
Microbiologic outcome	7-28 days
Pathogen eradication (eradication rates of individual pathogens)	7-28 days
Defervescence (defined as Tmax orally or rectally)	7-28 days
Resolution of neutropenia (return of ANC to >500 cells/mm3)	7-28 days

Trial Locations

Locations (1)

Pfizer Investigational Site