An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients


N/A
N/A
N/A
Not Enrolling
Both
Infection, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

determine the efficacy of daptomycin to treat gram positive infections

Outcome Time Frame:

day 7

Safety Issue:

No

Principal Investigator

Kevin High, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000466308

NCT ID:

NCT00296049

Start Date:

July 2005

Completion Date:

March 2006

Related Keywords:

  • Infection
  • Neutropenia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • infection
  • neutropenia
  • unspecified childhood solid tumor, protocol specific
  • Bacteremia
  • Neutropenia
  • Neoplasms

Name

Location
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096