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

Study Overview
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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).

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

Conditions
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Febrile Neutropenia

Intervention / Treatment
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* Drug: linezolid
* Drug: vancomycin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A.<br>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. | Drug: linezolid<br>* 600mg every 12 hours<br>* Other names: Zyvox;|
| Experimental: B.<br> | Drug: vancomycin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to defervescence |  | 7-28 days | 
| Resolution of neutropenia (return of ANC to >500 cells/mm3) |  | 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 |