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This study has been withdrawn prior to enrollment.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:
Comprehensive Cancer Center of Wake Forest University
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
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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:
Genetics Home Reference related topics:
cyclic neutropenia
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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 June 17, 2013