Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study
Overview
- Phase
- Phase 1
- Intervention
- cefepime hydrochloride
- Conditions
- Adult Acute Lymphoblastic Leukemia
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Defervescence (without hypothermia)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
Arm I (standard infusion)
Patients receive cefepime hydrochloride IV over 30 minutes.
Intervention: cefepime hydrochloride
Arm II (prolonged infusion)
Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
Intervention: cefepime hydrochloride
Outcomes
Primary Outcomes
Defervescence (without hypothermia)
Time Frame: 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 Outcomes
- Need for additional antimicrobials(approximately 24 days)
- Mortality (in-house)(approximately 24 days)
- Clinical success or failure(approximately 24 days)
- Time to defervescence(approximately 24 days)
- Hospital length of stay(approximately 24 days)
- Successful treatment of baseline infection(approximately 24 days)