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

NCT00296049 | Withdrawn FDA Drug

• 4 other identifiers: CDR0000466308CCCWFU-98804CUBIST-CCCWFU-98804CCCWFU-BG04-494
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; infection; neutropenia; unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• determine the efficacy of daptomycin to treat gram positive infections

  day 7

• determine the safety of daptomycin in neutropenic patients

  day 7

Study Arms (2)

vancomycin

ACTIVE COMPARATOR

Drug: vancomycin

daptomycin

EXPERIMENTAL

Drug: daptomycin

Interventions

daptomycin DRUG

daptomycin

vancomycin DRUG

vancomycin

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Infections; Neutropenia

Interventions

Daptomycin; Vancomycin

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates

Study Officials

• Kevin High, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 24, 2006
• Study Start: July 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

US (1)