Breast Cancer Clinical Trial

Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia

Summary

This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.

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Full Description

OBJECTIVES:

I. The objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia.

OUTLINE: Patients are randomized 1 of 2 treatment arms.

All patients receive cefepime hydrochloride intravenously (IV) over 30 minutes as their first dose.

ARM I: Patients receive cefepime hydrochloride intravenously (IV) over 30 minutes.

ARM II: Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.

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Eligibility Criteria

Inclusion Criteria:

Absolute neutrophil count < 500 cells/mm^3 or < 1000 cells/mm^3 with a predicted decrease to < 500 cells/mm^3
Temperature > 38.0 degrees Celsius
Received chemotherapy or stem-cell transplant as treatment for malignancy or myelodysplastic syndrome (MDS)
Cefepime prescribed at a dose of 2 grams IV every 8 hours

Exclusion Criteria:

Allergy to a cephalosporin antibiotic
Estimated creatinine clearance < 50 milliliters/minute
Concurrent anti-gram negative antimicrobials
Diagnostic criteria suggestive of sepsis
Circumstances which may make 3 hour infusion impractical
Solid tumor malignancy

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT01484015

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT01484015

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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