Clinical trial NCT01484015: Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia
Official title: Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Defervescence (without hypothermia)
timeFrame: 72 hours
Secondary outcomes:
measure: Clinical success or failure
timeFrame: approximately 24 days
measure: Need for additional antimicrobials
timeFrame: approximately 24 days
measure: Mortality (in-house)
timeFrame: approximately 24 days
measure: Time to defervescence
timeFrame: approximately 24 days
measure: Hospital length of stay
timeFrame: approximately 24 days
measure: Successful treatment of baseline infection
timeFrame: approximately 24 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: John Williamson
role: PRINCIPAL_INVESTIGATOR
References: