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


Phase 3
13 Years
N/A
Not Enrolling
Both
Febrile Neutropenia

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

7-28 days

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

M12600079

NCT ID:

NCT00035425

Start Date:

November 2001

Completion Date:

November 2002

Related Keywords:

  • Febrile Neutropenia
  • Fever
  • Neutropenia

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003