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This study has been withdrawn prior to enrollment.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
  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
Infection
Neutropenia
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: daptomycin
Drug: vancomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: July 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vancomycin Drug: vancomycin
Experimental: daptomycin Drug: daptomycin

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
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Kevin High, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00296049     History of Changes
Other Study ID Numbers: CDR0000466308, CCCWFU-98804, CUBIST-CCCWFU-98804, CCCWFU-BG04-494
Study First Received: February 23, 2006
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
unspecified adult solid tumor, protocol specific
infection
neutropenia
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Bacteremia
Neutropenia
Neoplasms
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014