Condition category
Infections and Infestations
Date applied
03/07/2006
Date assigned
17/08/2006
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

http://www.orange.bham.ac.uk

Contact information

Type

Scientific

Primary contact

Dr Ernest Marshall

ORCID ID

Contact details

Clatterbridge Centre for Oncology NHS Trust
Clatterbridge Road
Bebington
Wirral
Merseyside
CH63 4JY
United Kingdom
+44 (0) 151 334 1155
emarshall@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00445497

Protocol/serial number

MX3006

Study information

Scientific title

Acronym

ORANGE, Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge

Study hypothesis

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

North West MREC approved on 30/05/2006 (ref. no.: 06/MRE08/31).

Study design

Two arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Ciprofloxacin and Coamoxyclav

Primary outcome measures

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 trial start date

01/07/2006

Overall trial end date

01/07/2009

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400 registered; 320 randomised

Participant 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

Recruitment start date

01/07/2006

Recruitment end date

01/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Research and Enterprise Services
Aitcheson Building
Birmingham
B15 2TT
United Kingdom
+44 (0) 121 414 3898
res-ent@bham.ac.uk

Sponsor type

University/education

Website

http://www.res.bham.ac.uk/

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes