Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00035425
First received: May 3, 2002
Last updated: November 30, 2009
Last verified: November 2009
  Purpose

This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).


Condition Intervention Phase
Febrile Neutropenia
Drug: linezolid
Drug: vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections. [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbiologic outcome [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]
  • Pathogen eradication (eradication rates of individual pathogens) [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]
  • Defervescence (defined as Tmax orally or rectally) [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]
  • Time to defervescence [ Time Frame: 7-28 days ]
  • Resolution of neutropenia (return of ANC to >500 cells/mm3) [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]
  • Time to resolution of neutropenia [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]
  • Mortality rate (survival at 7 days after the end of therapy) [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: November 2001
Study Completion Date: November 2002
Arms Assigned Interventions
Experimental: A.
Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days.
Drug: linezolid
600mg every 12 hours
Other Name: Zyvox
Experimental: B. Drug: vancomycin
1gm every 12 hours. The dose of vancomycin intravenously may be adjusted for renal function, but the patient must be able to receive a 300 mL volume of intravenous fluid at the assigned dosing times of every 12 hours.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).

Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections.

Exclusion Criteria:

Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial.

Patients with endocarditis, osteomyelitis, meningitis, CNS infections.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035425

  Show 40 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00035425     History of Changes
Other Study ID Numbers: M12600079, A5951059
Study First Received: May 3, 2002
Last Updated: November 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fever
Neutropenia
Febrile Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014