Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Antibiotics, such as daptomycin and vancomycin, may be effective in treating bacteria in the blood. It is not yet known whether daptomycin is more effective than vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy. PURPOSE: This randomized clinical trial is studying daptomycin to see how well it works compared with vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy.

Detailed Description
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OBJECTIVES: Primary Compare the safety of daptomycin vs vancomycin in cancer patients with chemotherapy-induced neutropenia and gram-positive bacteremia. Compare the efficacy of these drugs, in terms of fever resolution, bacteremia resolution, inflammation indicators reduction, implanted catheter salvage, and reduced need for antifungal therapy, in these patients. OUTLINE: This is an open-label, randomized, pilot study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive daptomycin IV over 30 minutes once daily. Arm II: Patients receive vancomycin IV over 60 minutes twice daily. Treatment in both arms continues for approximately 7-14 days or until microbiologic failure, unsatisfactory clinical (symptomatic) response, or fever and neutropenia is resolved (absolute neutrophil count ≥ 1,000/mm^3 on ≥ 2 consecutive days). Patients may be removed from the study if the isolate is found to be sensitive to the original antibiotics or resistant to either of the study drugs. After completion of study therapy, patients are followed at 6 and 12 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
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An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients

Conditions
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Infection, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: daptomycin
* Drug: vancomycin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of a malignancy Chemotherapy-induced neutropenia (absolute neutrophil count < 500/mm^3) Two or more blood cultures positive for gram-positive cocci At least 0.2 colony-forming units/mL on lysis-centrifugation culture Currently receiving broad-spectrum antimicrobial therapy appropriate for febrile neutropenia No meningitis, endocarditis, osteomyelitis, or pneumonia (by clinical or radiologic criteria) PATIENT CHARACTERISTICS: Life expectancy ≥ 7 days No allergy or intolerance to vancomycin or daptomycin Creatinine clearance ≥ 30 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment No underlying myopathy or neurologic disease (e.g., Guillan-Barre or multiple sclerosis) PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent HMG CoA reductase inhibitors (statins) No concurrent gemfibrozil or clofibrate

Ages Eligible for Study
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Maximum Age: 120 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vancomycin<br> | Drug: vancomycin<br> <br> |
| Experimental: daptomycin<br> | Drug: daptomycin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the efficacy of daptomycin to treat gram positive infections |  | day 7 | 
| determine the safety of daptomycin in neutropenic patients |  | day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, infection, neutropenia, unspecified childhood solid tumor, protocol specific