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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01484015
First received: October 21, 2011
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy 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:

Genetic and Rare Diseases Information Center resources: Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Lymphosarcoma Lymphoma, Small Cleaved-cell, Diffuse Acute Lymphoblastic Leukemia Testicular Cancer Ovarian Epithelial Cancer Multiple Myeloma Chronic Myeloproliferative Disorders Hodgkin Lymphoma Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Neuroblastoma Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Lymphoblastic Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Mantle Cell Lymphoma Cutaneous T-cell Lymphoma Gestational Trophoblastic Tumor Ovarian Germ Cell Tumor Mycosis Fungoides Sezary Syndrome Anaplastic Plasmacytoma Germinoma Ovarian Cancer Hydatidiform Mole Neuroepithelioma Granulocytopenia
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 70
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484015

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: John Williamson Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01484015     History of Changes
Other Study ID Numbers: CCCWFU 02110, NCI-2011-02422
Study First Received: October 21, 2011
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Primary Myelofibrosis
Breast Neoplasms
Burkitt Lymphoma
Neoplasms
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Leukemia, Neutrophilic, Chronic
Leukemia, Prolymphocytic
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Mycoses
Mycosis Fungoides
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Myeloproliferative Disorders
Neuroblastoma
Neutropenia
Sezary Syndrome

ClinicalTrials.gov processed this record on August 28, 2014