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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01484015
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : July 18, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study
Study Start Date : February 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Defervescence (without hypothermia) [ Time Frame: 72 hours ]
    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 :
  1. Clinical success or failure [ Time Frame: approximately 24 days ]
  2. Need for additional antimicrobials [ Time Frame: approximately 24 days ]
  3. Mortality (in-house) [ Time Frame: approximately 24 days ]
  4. Time to defervescence [ Time Frame: approximately 24 days ]
  5. Hospital length of stay [ Time Frame: approximately 24 days ]
  6. Successful treatment of baseline infection [ Time Frame: approximately 24 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01484015

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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Principal Investigator: John Williamson Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT01484015    
Other Study ID Numbers: IRB00015247
NCI-2011-02422 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 02110 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burkitt Lymphoma
Leukemia, Myeloid
Multiple Myeloma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Hodgkin Disease
Lymphoma, Mantle-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Neoplasms, Germ Cell and Embryonal
Carcinoma, Ovarian Epithelial
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Neoplasms, Plasma Cell