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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00035425

Enrollment

120

Registered

2002-05-06

Start date

2001-11-30

Completion date

2002-11-30

Last updated

2009-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia

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).

Interventions

DRUGlinezolid

600mg every 12 hours

DRUGvancomycin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Pathogen eradication (eradication rates of individual pathogens)	7-28 days
Defervescence (defined as Tmax orally or rectally)	7-28 days
Time to defervescence	7-28 days
Microbiologic outcome	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
Resolution of neutropenia (return of ANC to >500 cells/mm3)	7-28 days

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026