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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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157