This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01484015
First received: October 21, 2011
Last updated: May 25, 2017
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
Intervention Model: Parallel Assignment
Masking: No masking
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:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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:
  • Clinical success or failure [ Time Frame: approximately 24 days ]
  • Need for additional antimicrobials [ Time Frame: approximately 24 days ]
  • Mortality (in-house) [ Time Frame: approximately 24 days ]
  • Time to defervescence [ Time Frame: approximately 24 days ]
  • Hospital length of stay [ Time Frame: approximately 24 days ]
  • Successful treatment of baseline infection [ Time Frame: approximately 24 days ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: John Williamson Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01484015     History of Changes
Other Study ID Numbers: CCCWFU 02110
NCI-2011-02422 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: October 21, 2011
Last Updated: May 25, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
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
Neuroblastoma
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Mycoses
Primary Myelofibrosis
Mycosis Fungoides

ClinicalTrials.gov processed this record on June 27, 2017