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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00296049
First received: February 23, 2006
Last updated: July 12, 2012
Last verified: July 2012

February 23, 2006
July 12, 2012
July 2005
March 2006   (final data collection date for primary outcome measure)
  • determine the efficacy of daptomycin to treat gram positive infections [ Time Frame: day 7 ] [ Designated as safety issue: No ]
  • determine the safety of daptomycin in neutropenic patients [ Time Frame: day 7 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00296049 on ClinicalTrials.gov Archive Site
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Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy
An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Infection
  • Neutropenia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Drug: daptomycin
  • Drug: vancomycin
  • Active Comparator: vancomycin
    Intervention: Drug: vancomycin
  • Experimental: daptomycin
    Intervention: Drug: daptomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00296049
CDR0000466308, CCCWFU-98804, CUBIST-CCCWFU-98804, CCCWFU-BG04-494
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Kevin High, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP