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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Febrile Neutropenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00035425
Pfizer
Completed
Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

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Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Febrile Neutropenia
  • Drug: linezolid
    600mg every 12 hours
    Other Name: Zyvox
  • 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.
    Intervention: Drug: linezolid
  • Experimental: B.
    Intervention: Drug: vancomycin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2002
Not Provided

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.

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Chile,   Colombia,   Finland,   Mexico,   Pakistan,   Peru,   United States,   Venezuela
Puerto Rico
 
NCT00035425
M12600079
A5951059
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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