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



Status:Completed
Conditions:Breast Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Brain Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Infectious Disease, Lymphoma, Lymphoma, Hematology, Hematology, Hematology, Hematology, Hematology, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:February 2011
End Date:October 2012

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Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study

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.

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.

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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