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

This study is ongoing, but not recruiting participants.

First Received on October 21, 2011.  
Last Updated on June 20, 2012  
History of Changes
This Clinical Trial Sponsored By: Comprehensive Cancer Center of Wake Forest University
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01484015
 

Purpose for Clinical Trial

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 Study Intervention
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

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
breast cancer
cyclic neutropenia
familial acute myeloid leukemia with mutated CEBPA
hemophilia
PDGFRA-associated chronic eosinophilic leukemia
MedlinePlus related topics:
Acute Myeloid Leukemia
Breast Cancer
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fever
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
Testicular Cancer
Drug Information available for:
Cefepime
Cefepime hydrochloride

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures For Clinical Trial:

  • 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.

Secondary Outcome Measures For Clinical Trial:

  • 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 s

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