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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00035425
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : December 1, 2009
Sponsor:
Information provided by:
Pfizer

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

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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
Actual Study Completion Date : November 2002


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.




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.


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


Locations
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United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033
United States, Illinois
Pfizer Investigational Site
Springfield, Illinois, United States, 62701-1014
Pfizer Investigational Site
Springfield, Illinois, United States, 62703
Pfizer Investigational Site
Springfield, Illinois, United States, 62769
Pfizer Investigational Site
Springfield, Illinois, United States, 62781
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10461
Pfizer Investigational Site
Bronx, New York, United States, 10467
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23226
Pfizer Investigational Site
Richmond, Virginia, United States, 23229
Pfizer Investigational Site
Richmond, Virginia, United States, 23249
Pfizer Investigational Site
Richmond, Virginia, United States, 23294-4367
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Pfizer Investigational Site
Federal Way, Washington, United States, 98003
Pfizer Investigational Site
Lakewood, Washington, United States, 98499
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, 1094
Pfizer Investigational Site
Cordoba, Argentina, 5000
Pfizer Investigational Site
Mendoza, Argentina, 5500
Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90020-090
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01509-900
Pfizer Investigational Site
São Paulo, SP, Brazil, 01409-902
Pfizer Investigational Site
São Paulo, Brazil, 04024-002
Pfizer Investigational Site
São Paulo, Brazil, 05651-901
Chile
Pfizer Investigational Site
Santiago, Chile
Colombia
Pfizer Investigational Site
Bogota, Bogota. DC, Colombia, NAP
Pfizer Investigational Site
Bogota, Bogota. DC, Colombia
Pfizer Investigational Site
Medellin, Colombia
Finland
Pfizer Investigational Site
Helsinki, Finland, FIN-00029 HYKS
Mexico
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45173
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, C.P. 64000
Pfizer Investigational Site
Mexico D.f., Mexico, C.P. 02990
Pakistan
Pfizer Investigational Site
Lahore, Punjab, Pakistan
Pfizer Investigational Site
Karachi, Pakistan, 74800
Peru
Pfizer Investigational Site
Lima, Peru, 13
Pfizer Investigational Site
Lima, Peru, 34
Venezuela
Pfizer Investigational Site
Caracas, Distrito Federal, Venezuela, 1041
Pfizer Investigational Site
Caracas, Venezuela, 1020
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00035425    
Other Study ID Numbers: M12600079
A5951059
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Vancomycin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action