NCT01484015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

October 21, 2011

Last Update Submit

July 16, 2018

Conditions

Adult Acute Lymphoblastic LeukemiaAdult Acute Myeloid LeukemiaAdult Burkitt LymphomaAdult Diffuse Large Cell LymphomaAdult Diffuse Mixed Cell LymphomaAdult Diffuse Small Cleaved Cell LymphomaAdult Hodgkin LymphomaAdult Immunoblastic Large Cell LymphomaAdult Lymphoblastic LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBreast CancerChronic Eosinophilic LeukemiaChronic Lymphocytic LeukemiaChronic Myelogenous LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaCutaneous T-cell Non-Hodgkin LymphomaDisseminated NeuroblastomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueGrade 1 Follicular LymphomaGrade 2 Follicular LymphomaGrade 3 Follicular LymphomaMalignant Testicular Germ Cell TumorMantle Cell LymphomaMarginal Zone LymphomaMultiple MyelomaMycosis Fungoides/Sezary SyndromeMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNeutropeniaNodal Marginal Zone B-cell LymphomaOvarian Epithelial CancerOvarian Germ Cell TumorPlasma Cell NeoplasmPoor Prognosis Metastatic Gestational Trophoblastic TumorPrimary MyelofibrosisProlymphocytic LeukemiaSmall Lymphocytic LymphomaSplenic Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Defervescence (without hypothermia)

    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.

    72 hours

Secondary Outcomes (6)

  • Clinical success or failure

    approximately 24 days

  • Need for additional antimicrobials

    approximately 24 days

  • Mortality (in-house)

    approximately 24 days

  • Time to defervescence

    approximately 24 days

  • Hospital length of stay

    approximately 24 days

  • +1 more secondary outcomes

Study Arms (2)

Arm I (standard infusion)

EXPERIMENTAL

Patients receive cefepime hydrochloride IV over 30 minutes.

Drug: cefepime hydrochloride

Arm II (prolonged infusion)

EXPERIMENTAL

Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.

Drug: cefepime hydrochloride

Interventions

cefepime hydrochlorideDRUG

Given IV

Also known as: cefepime, Maxipime
Arm I (standard infusion)Arm II (prolonged infusion)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBreast NeoplasmsPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLymphoma, T-Cell, CutaneousLymphoma, FollicularTesticular NeoplasmsLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneMultiple MyelomaMycosis FungoidesSezary SyndromeMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeutropeniaCarcinoma, Ovarian EpithelialNeoplasms, Plasma CellPrimary MyelofibrosisLeukemia, Prolymphocytic

Interventions

Cefepime

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphomaBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeukemia, B-CellMyeloproliferative DisordersLymphoma, T-CellEndocrine Gland NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersCarcinomaNeoplasms, Glandular and EpithelialOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, Female

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • John Williamson

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

December 2, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

US(1)