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

Wake Forest University Health Sciences70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adult Acute Lymphoblastic Leukemia Adult Acute Myeloid Leukemia Adult Burkitt Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Defervescence (without hypothermia)

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.

Time frame: 72 hours