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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00296049

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infection Neutropenia Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Drug: daptomycin Drug: vancomycin	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: vancomycin	Drug: vancomycin
Experimental: daptomycin	Drug: daptomycin

Arm

Intervention/Treatment

Active Comparator: vancomycin

Drug: vancomycin

Experimental: daptomycin

Drug: daptomycin

Outcome Measures

Primary Outcome Measures

determine the efficacy of daptomycin to treat gram positive infections [day 7]
determine the safety of daptomycin in neutropenic patients [day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)