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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00445497
First received: March 7, 2007
Last updated: August 9, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Lymphoma
Neutropenia
Psychosocial Effects of Cancer and Its Treatment
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: amoxicillin-clavulanate potassium
Drug: ciprofloxacin
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: 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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Total number of days of hospitalization (including unplanned readmission) (randomized patients)
  • Incidence of serious adverse events (randomized and registered patients)

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 400
Study Start Date: July 2007
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445497

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00445497     History of Changes
Other Study ID Numbers: CRUK-MX3006, CDR0000533828, CRUK-ORANGE, ISRCTN18467252, EU-20707
Study First Received: March 7, 2007
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
intraocular lymphoma
nodal marginal zone B-cell lymphoma
primary central nervous system non-Hodgkin lymphoma
primary central nervous system Hodgkin lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent mycosis fungoides/Sezary syndrome
recurrent small lymphocytic lymphoma
small intestine lymphoma
splenic marginal zone lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma

Additional relevant MeSH terms:
Ileal Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Nervous System Neoplasms
Neutropenia
Lymphoma, Large-Cell, Immunoblastic
Central Nervous System Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Jejunal Diseases

ClinicalTrials.gov processed this record on July 09, 2014