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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Comprehensive Cancer Center of Wake Forest University

ClinicalTrials.gov Identifier:

NCT01484015

First received: October 21, 2011

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 21, 2011

Last Updated Date

February 27, 2013

Start Date ^ICMJE

February 2011

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Defervescence (without hypothermia) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

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 Measures ^ICMJE

Defervescence (without hypothermia) [ Time Frame: By 72 hours ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01484015 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical success or failure [ Time Frame: approximately 24 days ] [ Designated as safety issue: No ]
Need for additional antimicrobials [ Time Frame: approximately 24 days ] [ Designated as safety issue: No ]
Mortality (in-house) [ Time Frame: approximately 24 days ] [ Designated as safety issue: No ]
Time to defervescence [ Time Frame: approximately 24 days ] [ Designated as safety issue: No ]
Hospital length of stay [ Time Frame: approximately 24 days ] [ Designated as safety issue: No ]
Successful treatment of baseline infection [ Time Frame: approximately 24 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Clinical success or failure [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
Need for additional antimicrobials [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
Mortality (in-house) [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
Time to defervescence [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
Hospital length of stay [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
Successful treatment of baseline infection [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Adult Acute Lymphoblastic Leukemia
Adult Acute Myeloid Leukemia
Adult Burkitt Lymphoma
Adult Diffuse Large Cell Lymphoma
Adult Diffuse Mixed Cell Lymphoma
Adult Diffuse Small Cleaved Cell Lymphoma
Adult Hodgkin Lymphoma
Adult Immunoblastic Large Cell Lymphoma
Adult Lymphoblastic Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Breast Cancer
Chronic Eosinophilic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Chronic Myelomonocytic Leukemia
Chronic Neutrophilic Leukemia
Cutaneous T-cell Non-Hodgkin Lymphoma
Disseminated Neuroblastoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3 Follicular Lymphoma
Malignant Testicular Germ Cell Tumor
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Multiple Myeloma
Mycosis Fungoides/Sezary Syndrome
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Neutropenia
Nodal Marginal Zone B-cell Lymphoma
Ovarian Epithelial Cancer
Ovarian Germ Cell Tumor
Plasma Cell Neoplasm
Poor Prognosis Metastatic Gestational Trophoblastic Tumor
Primary Myelofibrosis
Prolymphocytic Leukemia
Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma

Intervention ^ICMJE

Drug: cefepime hydrochloride

Given IV

Other Names:

cefepime
Maxipime

Study Arm (s)

Experimental: Arm I (standard infusion)
Patients receive cefepime hydrochloride IV over 30 minutes.

Intervention: Drug: cefepime hydrochloride
Experimental: Arm II (prolonged infusion)
Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.

Intervention: Drug: cefepime hydrochloride

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01484015

Other Study ID Numbers ^ICMJE

CCCWFU 02110, NCI-2011-02422

Has Data Monitoring Committee

Responsible Party

Comprehensive Cancer Center of Wake Forest University

Study Sponsor ^ICMJE

Comprehensive Cancer Center of Wake Forest University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

John Williamson

Wake Forest University

Information Provided By

Comprehensive Cancer Center of Wake Forest University

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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