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

This study has been completed.

First Received: May 3, 2002 Last Updated: August 13, 2009 History of Changes

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

Show 21 Study Locations

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 05, 2009