Treatment of Neutropenic Patients With Fever Who Are Suspected to Have a Gram Positive Infection (a Specific Kind of Bacteria) - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00035425

Purpose

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	Intervention	Phase
Neutropenia Fever Gram-Positive Bacterial Infections Neoplasms	Drug: Antibiotic Drug: Vancomycin	Phase III

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bacterial Infections Cancer Fever

Drug Information available for: Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035425

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Locations

United States, California
Research Center
San Diego, California, United States, 92134
Research Center
Los Angeles, California, United States, 90033
Research Center
Orange, California, United States, 92868
United States, Florida
Research Center
Miami, Florida, United States, 33136
United States, Illinois
Research Center
Springfield, Illinois, United States, 62701
Research Center
Maywood, Illinois, United States, 60153
United States, Kentucky
Research Center
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Research Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Research Center
Kalamazoo, Michigan, United States, 49001
United States, New Jersey
Research Center
Perth Amboy, New Jersey, United States, 08861
United States, New York
Research Center
Bronx, New York, United States, 10467-2490
United States, Ohio
Research Center
Youngstown, Ohio, United States, 44501
United States, Tennessee
Research Center
Jackson, Tennessee, United States, 38301
United States, Texas
Research Center
Houston, Texas, United States, 77030-4211
Research Center
Houston, Texas, United States, 77030
United States, Virginia
Research Center
Richmond, Virginia, United States, 23249
Research Center
Falls Church, Virginia, United States, 22042
Research Center
Richmond, Virginia, United States, 23294
United States, Washington
Research Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Research Center
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
Research Center
Hato Rey, Puerto Rico, 00985

Sponsors and Collaborators

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	M12600079
Study First Received:	May 3, 2002
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00035425 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacia

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Communicable Diseases
Hematologic Diseases
Agranulocytosis
Leukocyte Disorders
Body Temperature Changes
Infection
Pharmacologic Actions

Fever
Anti-Bacterial Agents
Neutropenia
Signs and Symptoms
Neoplasms
Gram-Positive Bacterial Infections
Therapeutic Uses
Vancomycin
Leukopenia

ClinicalTrials.gov processed this record on November 27, 2009