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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484015
• Other study ID #: IRB00015247
• Secondary ID: NCI-2011-02422CC
• Status: Completed
• Phase: Phase 1
• Start date: February 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Burkitt Lymphoma
• 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
• Febrile Neutropenia
• Germinoma
• Gestational Trophoblastic Disease
• Grade 1 Follicular Lymphoma
• Grade 2 Follicular Lymphoma
• Grade 3 Follicular Lymphoma
• Hodgkin Disease
• Hypereosinophilic Syndrome
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Leukemia, Prolymphocytic
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Immunoblastic
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Malignant Testicular Germ Cell Tumor
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Multiple Myeloma
• Mycoses
• Mycosis Fungoides
• Mycosis Fungoides/Sezary Syndrome
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Glandular and Epithelial
• Neoplasms, Plasma Cell
• Neuroblastoma
• Neutropenia
• Nodal Marginal Zone B-cell Lymphoma
• Ovarian Epithelial Cancer
• Ovarian Germ Cell Tumor
• Ovarian Neoplasms
• Plasma Cell Neoplasm
• Plasmablastic Lymphoma
• Plasmacytoma
• Poor Prognosis Metastatic Gestational Trophoblastic Tumor
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia
• Primary Myelofibrosis
• Prolymphocytic Leukemia
• Sezary Syndrome
• Small Lymphocytic Lymphoma
• Splenic Marginal Zone Lymphoma
• Syndrome
• Testicular Neoplasms
• Trophoblastic Neoplasms

Intervention

Drug:
• cefepime hydrochloride
Given IV

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defervescence (without hypothermia)	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	Clinical success or failure		approximately 24 days
Secondary	Need for additional antimicrobials		approximately 24 days
Secondary	Mortality (in-house)		approximately 24 days
Secondary	Time to defervescence		approximately 24 days
Secondary	Hospital length of stay		approximately 24 days
Secondary	Successful treatment of baseline infection		approximately 24 days