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

Information source: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Intervention: daptomycin (Drug); vancomycin (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Comprehensive Cancer Center of Wake Forest University

Official(s) and/or principal investigator(s):
Kevin High, MD, Study Chair, Affiliation: Comprehensive Cancer Center of Wake Forest University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

determine the efficacy of daptomycin to treat gram positive infections

determine the safety of daptomycin in neutropenic patients

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States
Additional Information

Starting date: July 2005
Last updated: July 12, 2012

Page last updated: August 23, 2015

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