Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University Identifier:
First received: October 21, 2011
Last updated: July 10, 2013
Last verified: July 2013
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
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: Lymphosarcoma Hodgkin Lymphoma Multiple Myeloma Lymphoma, Large-cell Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Chronic Myelomonocytic Leukemia Myelofibrosis Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Neuroblastoma B-cell Lymphoma Ovarian Epithelial Cancer Diffuse Large B-Cell Lymphoma Follicular Lymphoma Burkitt Lymphoma Chronic Myeloid Leukemia Granulocytopenia Testicular Cancer Mantle Cell Lymphoma Gestational Trophoblastic Tumor Mycosis Fungoides Cutaneous T-cell Lymphoma Chronic Myeloproliferative Disorders Sezary Syndrome Ovarian Germ Cell Tumor Myelodysplastic/myeloproliferative Disease Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia Ovarian Cancer Anaplastic Plasmacytoma Hypereosinophilic Syndrome Neuroepithelioma
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:


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01484015

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
National Cancer Institute (NCI)
Principal Investigator: John Williamson Wake Forest School of Medicine
  More Information

Responsible Party: Comprehensive Cancer Center of Wake Forest University 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:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hodgkin Disease
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Mycosis Fungoides
Primary Myelofibrosis
Lymphoma, T-Cell
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous processed this record on October 21, 2016