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

July 16, 2018 updated by: Wake Forest University Health Sciences

Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I (standard infusion)
Patients receive cefepime hydrochloride IV over 30 minutes.
Drug: cefepime hydrochloride
Given IV
Other Names:
  • Maxipime
  • cefepime
EXPERIMENTAL: Arm II (prolonged infusion)
Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
Drug: cefepime hydrochloride
Given IV
Other Names:
  • Maxipime
  • cefepime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John Williamson, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

November 30, 2011

First Posted (ESTIMATE)

December 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00015247
  • NCI-2011-02422 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CCCWFU 02110 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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