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

Sponsor

Clatterbridge Centre for Oncology (Other)

Overall Status

Unknown status

CT.gov ID

NCT00445497

Collaborator

(none)

400

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

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]

Study Start Date :

Jul 1, 2007

Anticipated Primary Completion Date :

Jul 1, 2010

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England	United Kingdom	GL53 7AN
2	Princess Royal Hospital at Hull and East Yorkshire NHS Trust	Hull	England	United Kingdom	HU8 9HE
3	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
4	Clatterbridge Centre for Oncology	Merseyside	England	United Kingdom	CH63 4JY
5	Northampton General Hospital	Northampton	England	United Kingdom	NN1 5BD
6	Peterborough Hospitals Trust	Peterborough	England	United Kingdom	PE3 6DA
7	Cancer Research Centre at Weston Park Hospital	Sheffield	England	United Kingdom	S1O 2SJ
8	Airedale General Hospital	West Yorkshire	England	United Kingdom	BD20 6TD
9	Western Infirmary	Glasgow	Scotland	United Kingdom	G11 6NT
10	Ysbyty Gwynedd	Bangor	Wales	United Kingdom	LL57 2PW