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

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ClinicalTrials.gov Identifier: NCT00035425
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : December 1, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Febrile Neutropenia Drug: linezolid Drug: vancomycin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2001
Study Completion Date : November 2002

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Microbiologic outcome [ Time Frame: 7-28 days ]
  2. Pathogen eradication (eradication rates of individual pathogens) [ Time Frame: 7-28 days ]
  3. Defervescence (defined as Tmax orally or rectally) [ Time Frame: 7-28 days ]
  4. Time to defervescence [ Time Frame: 7-28 days ]
  5. Resolution of neutropenia (return of ANC to >500 cells/mm3) [ Time Frame: 7-28 days ]
  6. Time to resolution of neutropenia [ Time Frame: 7-28 days ]
  7. Mortality rate (survival at 7 days after the end of therapy) [ Time Frame: 7-28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035425

  Show 39 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00035425     History of Changes
Other Study ID Numbers: M12600079
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Febrile Neutropenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action