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NCT00035425

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

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2002-11-30

Brief Summary

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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

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Conditions

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Febrile Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A.

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.

Group Type EXPERIMENTAL

linezolid

Intervention Type DRUG

600mg every 12 hours

B.

Group Type EXPERIMENTAL

vancomycin

Intervention Type DRUG

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.

Interventions

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linezolid

600mg every 12 hours

Intervention Type DRUG

vancomycin

Intervention Type DRUG

Other Intervention Names

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Zyvox

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Springfield, Illinois, United States

Site Status

Pfizer Investigational Site

Springfield, Illinois, United States

Site Status

Pfizer Investigational Site

Springfield, Illinois, United States

Site Status

Pfizer Investigational Site

Springfield, Illinois, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status