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

October 21, 2011
July 10, 2013
February 2011
June 2012   (final data collection date for primary outcome measure)
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.
Defervescence (without hypothermia) [ Time Frame: By 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.
Complete list of historical versions of study NCT01484015 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinical success or failure [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
  • Need for additional antimicrobials [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
  • Mortality (in-house) [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
  • Time to defervescence [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
  • Successful treatment of baseline infection [ Time Frame: Length of stay average 24 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia
Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Given IV
Other Names:
  • cefepime
  • Maxipime
  • Experimental: Arm I (standard infusion)
    Patients receive cefepime hydrochloride IV over 30 minutes.
    Intervention: Drug: cefepime hydrochloride
  • Experimental: Arm II (prolonged infusion)
    Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
    Intervention: Drug: cefepime hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01484015
CCCWFU 02110, NCI-2011-02422
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: John Williamson Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP