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

Phase 1

Completed

• Conditions: Adult Acute Lymphoblastic Leukemia; Adult Burkitt Lymphoma; Adult Lymphoblastic Lymphoma; Myelodysplastic/Myeloproliferative Neoplasms; Neutropenia; Adult Acute Myeloid Leukemia; Adult Diffuse Large Cell Lymphoma; Adult Diffuse Mixed Cell Lymphoma; Adult Diffuse Small Cleaved Cell Lymphoma; Mantle Cell Lymphoma
• Interventions: Drug: cefepime hydrochloride

• Registration Number: NCT01484015
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (standard infusion)	cefepime hydrochloride	Patients receive cefepime hydrochloride IV over 30 minutes.
Arm II (prolonged infusion)	cefepime hydrochloride	Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.

Primary Outcome Measures

Name	Time	Method
Defervescence (without hypothermia)	72 hours	Comparison between groups will be done using the chi square test. T-tests will be used for continues variables. Survival data will be estimated using the Kaplan-Meier method, with the formal test of group comparisons done using Cox's Proportional Hazards Model.

Secondary Outcome Measures

Name	Time	Method
Clinical success or failure	approximately 24 days
Need for additional antimicrobials	approximately 24 days
Mortality (in-house)	approximately 24 days
Time to defervescence	approximately 24 days
Hospital length of stay	approximately 24 days
Successful treatment of baseline infection	approximately 24 days

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States