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

November 30, 2009 updated by: Pfizer

A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Argentina
      • Buenos Aires, Argentina, 1094
        • Pfizer Investigational Site
      • Cordoba, Argentina, 5000
        • Pfizer Investigational Site
      • Mendoza, Argentina, 5500
        • Pfizer Investigational Site
  • Brazil
      • São Paulo, Brazil, 04024-002
        • Pfizer Investigational Site
      • São Paulo, Brazil, 05651-901
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazil, 90020-090
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 01509-900
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 01409-902
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile
        • Pfizer Investigational Site
  • Colombia
      • Medellin, Colombia
        • Pfizer Investigational Site
    • Bogota. DC
      • Bogota, Bogota. DC, Colombia, NAP
        • Pfizer Investigational Site
      • Bogota, Bogota. DC, Colombia
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, FIN-00029 HYKS
        • Pfizer Investigational Site
  • Mexico
      • Mexico D.f., Mexico, C.P. 02990
        • Pfizer Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45173
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, C.P. 64000
        • Pfizer Investigational Site
  • Pakistan
      • Karachi, Pakistan, 74800
        • Pfizer Investigational Site
    • Punjab
      • Lahore, Punjab, Pakistan
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, 13
        • Pfizer Investigational Site
      • Lima, Peru, 34
        • Pfizer Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62701-1014
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62769
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62781
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10467
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23249
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23226
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294-4367
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, United States, 98003
        • Pfizer Investigational Site
      • Lakewood, Washington, United States, 98499
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
  • Venezuela
      • Caracas, Venezuela, 1020
        • Pfizer Investigational Site
    • Distrito Federal
      • Caracas, Distrito Federal, Venezuela, 1041
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Zyvox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7-28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Microbiologic outcome
Time Frame: 7-28 days
7-28 days
Pathogen eradication (eradication rates of individual pathogens)
Time Frame: 7-28 days
7-28 days
Defervescence (defined as Tmax orally or rectally)
Time Frame: 7-28 days
7-28 days
Time to defervescence
Time Frame: 7-28 days
7-28 days
Resolution of neutropenia (return of ANC to >500 cells/mm3)
Time Frame: 7-28 days
7-28 days
Time to resolution of neutropenia
Time Frame: 7-28 days
7-28 days
Mortality rate (survival at 7 days after the end of therapy)
Time Frame: 7-28 days
7-28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Estimate)

December 1, 2009

Last Update Submitted That Met QC Criteria

November 30, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12600079
  • A5951059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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