Status:
COMPLETED
Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Lymphoblastic Leukemia
Adult Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 cefe...
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01484015
Start Date
February 1 2011
End Date
October 1 2012
Last Update
July 18 2018
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157