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

ISRCTN	ISRCTN18467252
DOI	https://doi.org/10.1186/ISRCTN18467252
ClinicalTrials.gov number	NCT00445497
Secondary identifying numbers	MX3006

Submission date: 03/07/2006
Registration date: 17/08/2006
Last edited: 05/11/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Ernest Marshall
Scientific

Clatterbridge Centre for Oncology NHS Trust
Clatterbridge Road
Bebington
Wirral
Merseyside
CH63 4JY
United Kingdom

Phone	+44 (0) 151 334 1155
Email	emarshall@nhs.net

Study information

Study design	Two arm randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	ORANGE, Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge
Study objectives	To determine, in the setting of the management of patients with solid tumours and lymphoma, whether in-patients treated with oral antibacterial therapy for neutropenic sepsis and at low risk for complications from infection can be identified for early discharge using the criteria of symptomatic improvement and temperature less than 37.8°C irrespective of neutrophil recovery.
Ethics approval(s)	North West MREC approved on 30/05/2006 (ref. no.: 06/MRE08/31).
Health condition(s) or problem(s) studied	Neutropenic sepsis
Intervention	Treatment with oral Ciprofloxacin 750 mg twice daily and Co-amoxyclav 625 mg three times a day, and daily temperature readings. For the research arm patients will be discharged home early.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Ciprofloxacin and Coamoxyclav
Primary outcome measure	1. Total number of days of hospitalisation (including unplanned readmission) 2. Incidence of serious adverse events
Secondary outcome measures	1. Incidence of treatment failure as defined by the necessity for change in antibacterial therapy 2. Incidence of unplanned readmissions 3. Patient acceptability 4. Toxicity attributed to oral antibiotic therapy 5. Costs to health service
Overall study start date	01/07/2006
Completion date	01/07/2009
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	400 registered; 320 randomised
Key inclusion criteria	1. No previous participation in ORANGE for neutropenic episode 2. Undergoing cytotoxic chemotherapy to treat solid tumours or lymphoma 3. An Absolute Neutrophil Count (ANC) of more than or equal to 0.5 x 10^9 l. Patients are also eligible if their ANC is between 0.5 1 x 10^9 l but anticipated to fall to less than or equal to 0.5 x 10^9 l within 24 hours of entry into the study 4. A temperature of more than or equal to 38.5°C on a single measurement or more than 38.0°C on more than one occasion, at least one hour apart, one of which could be measured by the patient prior to admission 5. Patients with neutropenic fever (defined as above) at low risk of complications according to the Multinational Association of Supportive Care in Cancer (MASCC) prognostic index score more than or equal to 21 6. Age is 18 years or over 7. Compliant patient and appropriate for early discharge in the opinion of the investigator. All patients are required to have a responsible adult living with them who would be prepared to act as a carer if the patient were eligible for early discharge. Either patient or carer should be able to read a thermometer 8. Able to tolerate oral medication 9. Written informed consent obtained
Key exclusion criteria	1. Neutropenic fever judged by the clinician to be at high risk of complications 2. Allergies to oral antibiotics or penicillin used in ORANGE 3. Clinical condition necessitates intravenous fluid support 4. Central venous catheter associated infection or evidence of infection thought in the opinion of the investigator not to be adequately treated by the study antibiotics 5. Previous bone marrow transplant or peripheral blood stem cell transplant 6. Associated co-morbidity that requires hospitalisation and management 7. Received antibiotic therapy, including prophylactic antibiotics, within the last 72 hours (prophylactic septrin for pneumocystis, acyclovir or antifungals are acceptable) 8. Receiving Granulocyte Colony Stimulating Factor (G-CSF) 9. Known Human Immunodeficiency Virus (HIV) positive 10. Patients treated for leukaemia
Date of first enrolment	01/07/2006
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clatterbridge Centre for Oncology NHS Trust

Merseyside
CH63 4JY
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Research and Enterprise Services
Aitcheson Building
Birmingham
B15 2TT
England
United Kingdom

Phone	+44 (0) 121 414 3898
Email	res-ent@bham.ac.uk
Website	http://www.res.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Charity

Clinical Trials Advisory & Awards Committee (CTAAC) Ref: C1810/A4818

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan