Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia

August 9, 2013 updated by: Clatterbridge Centre for Oncology

A Prospective Randomised Phase III Trial of Early Hospital Discharge Versus Standard Inpatient Management of Cancer Patients With Low-Risk Febrile Neutropenia Receiving Oral Antibiotics. Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge [ORANGE]

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Identify cancer patients who are low-risk inpatients and meet criteria for early discharge (i.e., symptomatic improvement and temperature ≤ 37.8°C) after receiving oral antibiotics for febrile neutropenia.

OUTLINE: This is a randomized, prospective, multicenter study. Patients are stratified by disease type (lymphoma vs solid tumor), duration of registration (< 48 hours vs > 48 hours), and participating center.

Patients receive oral amoxicillin-clavulanate potassium 3 times daily and oral ciprofloxacin twice daily on admission to the hospital. Treatment continues for 7 days in the absence of clinical deterioration or unacceptable toxicity. Patients are assessed as inpatients after ≥ 24 and up to 72 hours after the first antibiotic dose. Patients showing clear response (i.e., symptomatic improvement irrespective of neutrophil recovery, temperature ≤ 37.8 C for 24 hours) and who continue to meet study eligibility criteria are randomized to 1 of 2 arms.

  • Arm I (early discharge): Patients are discharged home and instructed to remain in daily contact with hospital staff to report temperature and symptoms until completion of oral antibiotic regimen.
  • Arm II (standard management): Patients continue their antibiotic course in hospital and are discharged according to local guidelines and the following additional criteria: subjective improvement, afebrile (≤ 37°C for 24 hours), and absolute neutrophil count ≥ 500/mm³ and rising.

Patients in both arms complete a daily diary documenting daily temperature readings, symptoms, and toxicities. Patients also complete a Health Questionnaire and a Cancer Worries Inventory Booklet at baseline, in the hospital immediately after randomization, and at completion of oral antibiotics or resolution of neutropenic febrile episode.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Recruiting
        • Gloucestershire Oncology Centre at Cheltenham General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-0124-2222-2222
      • Hull, England, United Kingdom, HU8 9HE
        • Recruiting
        • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-0148-2701151
      • Leicester, England, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-011-6254-1414
      • Merseyside, England, United Kingdom, CH63 4JY
        • Recruiting
        • Clatterbridge Centre for Oncology
        • Contact:
          • Ernest Marshall, MD
          • Phone Number: 44-151-334-1155
      • Northampton, England, United Kingdom, NN1 5BD
        • Recruiting
        • Northampton General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-016-0463-4700
      • Peterborough, England, United Kingdom, PE3 6DA
        • Recruiting
        • Peterborough Hospitals Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-0173-387-4000
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Recruiting
        • Cancer Research Centre at Weston Park Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-114-226-5000
      • West Yorkshire, England, United Kingdom, BD20 6TD
        • Recruiting
        • Airedale General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-015-356-2511
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Recruiting
        • Western Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-0114-226-5000
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
        • Recruiting
        • Ysbyty Gwynedd
        • Contact:
          • Contact Person
          • Phone Number: 44-0124-838-4384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Total number of days of hospitalization (including unplanned readmission) (randomized patients)
Incidence of serious adverse events (randomized and registered patients)

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clatterbridge Centre for Oncology

Investigators

  • Study Chair: Ernest Marshall, MD, Clatterbridge Centre for Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRUK-MX3006
  • CDR0000533828 (Registry Identifier: PDQ (Physician Data Query))
  • CRUK-ORANGE
  • ISRCTN18467252
  • EU-20707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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