NCT00445497

Brief Summary

RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia. PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

10 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

August 12, 2013

Status Verified

May 1, 2007

Enrollment Period

3 years

First QC Date

March 7, 2007

Last Update Submit

August 9, 2013

Conditions

Brain and Central Nervous System TumorsLymphomaNeutropeniaPsychosocial Effects of Cancer and Its TreatmentSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

psychosocial effects of cancer and its treatmentanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissueintraocular lymphomanodal marginal zone B-cell lymphomaprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent small lymphocytic lymphomasmall intestine lymphomasplenic marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult T-cell leukemia/lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III mycosis fungoides/Sezary syndromestage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult T-cell leukemia/lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV mycosis fungoides/Sezary syndromestage IV small lymphocytic lymphomaWaldenström macroglobulinemiaunspecified adult solid tumor, protocol specificneutropeniastage I adult Burkitt lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage I adult Hodgkin lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage II adult Hodgkin lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomarecurrent adult T-cell leukemia/lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomaadult grade III lymphomatoid granulomatosisrecurrent adult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphoma

Outcome Measures

Primary Outcomes (2)

  • Total number of days of hospitalization (including unplanned readmission) (randomized patients)

  • Incidence of serious adverse events (randomized and registered patients)

Secondary Outcomes (5)

  • Incidence of treatment failure as defined by the necessity for change in antibiotic therapy (randomized and registered patients)

  • Incidence of unplanned readmissions (randomized patients)

  • Patient acceptability of randomized discharge policy as measured by Health Questionnaire, Cancer Worries Inventory Booklet, and Patient Daily Diary (randomized patients)

  • Toxicity attributed to oral antibiotic therapy as measured by NCI CTCAE v3.0 (randomized and registered patients)

  • Health service costs (randomized patients)

Interventions

amoxicillin-clavulanate potassiumDRUG
ciprofloxacinDRUG
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of solid tumor or lymphoma AND meets the following criteria: * Low-risk patient, defined as Multinational Association for Supportive Care in Cancer prognostic index score ≥ 21 * Presents with neutropenic fever defined as follows: * Absolute neutrophil count ≤ 500/mm³ OR \< 1,000/mm³ but anticipated to fall to ≤ 500/mm³ within 24 hours of study entry * Temperature ≥ 38.5°C on a single measurement or ≥ 38.0°C on \> 1 occasion (one of which could be measured by the patient prior to admission) ≥ 1 hour apart * Undergoing concurrent cytotoxic chemotherapy for treatment of solid tumors or lymphoma * No leukemia PATIENT CHARACTERISTICS: * Compliant and appropriate for early discharge * Able to read a thermometer (patient or caregiver) * Able to tolerate oral medication * Must have a responsible adult caregiver if eligible for early discharge * No known allergy to oral antibiotics or penicillin * No requirement for IV fluid support * No central venous catheter-associated infection or evidence of infection not amenable to treatment by study antibiotics * No neutropenic fever at high risk of complications * No associated comorbidity that requires hospitalization and management * No known HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior participation in this study for neutropenic episode * No prior bone marrow transplantation or peripheral blood stem cell transplantation * No prior treatment for leukemia * More than 72 hours since prior antibiotics, including prophylactic antibiotics * Prophylactic septrin (for pneumocystis), acyclovir, or antifungals are allowed * No concurrent granulocyte colony-stimulating factor therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

RECRUITING

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

RECRUITING

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

RECRUITING

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

RECRUITING

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

RECRUITING

Airedale General Hospital

West Yorkshire, England, BD20 6TD, United Kingdom

RECRUITING

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

RECRUITING

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaNeutropeniaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyIntraocular LymphomaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellPrecursor T-Cell Lymphoblastic Leukemia-LymphomaWaldenstrom MacroglobulinemiaLymphoma, Extranodal NK-T-Cell

Interventions

Amoxicillin-Potassium Clavulanate CombinationCiprofloxacinPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte DisordersLymphoma, T-CellLymphadenopathyEye NeoplasmsLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsFluoroquinolones4-QuinolonesQuinolonesQuinolinesRehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ernest Marshall, MD

    Clatterbridge Centre for Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2010

Last Updated

August 12, 2013

Record last verified: 2007-05

Locations

GB(10)