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Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy
This study has been completed.
Study NCT00296049   Information provided by National Cancer Institute (NCI)
First Received: February 23, 2006   Last Updated: May 9, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

February 23, 2006
May 9, 2009
July 2005
 
 
Complete list of historical versions of study NCT00296049 on ClinicalTrials.gov Archive Site
 
 
 
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
Supportive Care, Randomized, Open Label
  • Infection
  • Neutropenia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Drug: daptomycin
  • Drug: vancomycin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
 
 

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
 
No
 
United States
 
 
NCT00296049
 
CCCWFU-98804, CUBIST-CCCWFU-98804, CCCWFU-BG04-494
Wake Forest University
National Cancer Institute (NCI)
Study Chair: Kevin High, MD Wake Forest University
National Cancer Institute (NCI)
March 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.