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.|
|ClinicalTrials.gov Identifier: NCT01484015|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : July 18, 2018
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Arm I (standard infusion)
Patients receive cefepime hydrochloride IV over 30 minutes.
Drug: cefepime hydrochloride
Experimental: Arm II (prolonged infusion)
Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.
Drug: cefepime hydrochloride
- 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.
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01484015
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||John Williamson||Wake Forest University Health Sciences|