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

• Status: Withdrawn
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Daptomycin; Vancomycin

Criteria

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