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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Febrile Neutropenia

Treatments: Drug: vancomycin; Drug: linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035425

A5951059

M12600079

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

A.

Experimental group

Description:

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.

Treatment:

Drug: linezolid

B.

Experimental group

Treatment:

Drug: vancomycin