Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00296049

Purpose

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	Intervention
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Drug: daptomycin Drug: vancomycin

MedlinePlus related topics: Cancer

Drug Information available for: Daptomycin Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label
Official Title:	An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	July 2005

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296049

Locations

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

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Kevin High, MD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000466308, CCCWFU-98804, CUBIST-CCCWFU-98804, CCCWFU-BG04-494
Study First Received:	February 23, 2006
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00296049 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
infection
neutropenia
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:

Daptomycin
Anti-Bacterial Agents
Neutropenia
Vancomycin
Bacteremia

Additional relevant MeSH terms:

Daptomycin
Anti-Infective Agents
Anti-Bacterial Agents

Therapeutic Uses
Vancomycin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009