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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01484015

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: cefepime hydrochloride	Phase 1

Detailed Description

OBJECTIVES:

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (standard infusion) Patients receive cefepime hydrochloride IV over 30 minutes.	Drug: cefepime hydrochloride Given IV Other Names: cefepime Maxipime
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: cefepime Maxipime

Arm

Intervention/Treatment

Experimental: Arm I (standard infusion)

Patients receive cefepime hydrochloride IV over 30 minutes.

Drug: cefepime hydrochloride

Given IV

Other Names:

cefepime

Maxipime

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:

cefepime

Maxipime

Outcome Measures

Primary Outcome Measures

Defervescence (without hypothermia) [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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