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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296049
Recruitment Status : Withdrawn
First Posted : February 24, 2006
Last Update Posted : January 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 Not Applicable

Detailed Description:



  • 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 Type : Interventional  (Clinical Trial)
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 : July 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

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

Primary Outcome Measures :
  1. determine the efficacy of daptomycin to treat gram positive infections [ Time Frame: day 7 ]
  2. determine the safety of daptomycin in neutropenic patients [ Time Frame: day 7 ]

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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)


  • See Disease Characteristics
  • No concurrent HMG CoA reductase inhibitors (statins)
  • No concurrent gemfibrozil or clofibrate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296049

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Kevin High, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00296049     History of Changes
Other Study ID Numbers: CDR0000466308
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: July 2012

Keywords provided by Wake Forest University Health Sciences:
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents