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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: 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.


Original Primary Outcome: Defervescence (without hypothermia) [ Time Frame: By 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.


Current Secondary Outcome:

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


Original Secondary Outcome:

  • Clinical success or failure [ Time Frame: Length of stay average 24 days ]
  • Need for additional antimicrobials [ Time Frame: Length of stay average 24 days ]
  • Mortality (in-house) [ Time Frame: Length of stay average 24 days ]
  • Time to defervescence [ Time Frame: Length of stay average 24 days ]
  • Hospital length of stay [ Time Frame: Length of stay average 24 days ]
  • Successful treatment of baseline infection [ Time Frame: Length of stay average 24 days ]


Information By: Wake Forest University Health Sciences

Dates:
Date Received: October 21, 2011
Date Started: February 2011
Date Completion:
Last Updated: January 17, 2017
Last Verified: July 2013