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

Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors; Lymphoma; Neutropenia; Psychosocial Effects of Cancer and Its Treatment; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: amoxicillin-clavulanate potassium (Drug); ciprofloxacin (Drug); psychosocial assessment and care (Procedure); quality-of-life assessment (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Clatterbridge Centre for Oncology

Official(s) and/or principal investigator(s):
Ernest Marshall, MD, Study Chair, Affiliation: Clatterbridge Centre for Oncology

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.

Clinical Details

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 design: Allocation: Randomized, Primary Purpose: Supportive Care

Primary outcome:

Total number of days of hospitalization (including unplanned readmission) (randomized patients)

Incidence of serious adverse events (randomized and registered patients)

Secondary outcome:

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)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England GL53 7AN, United Kingdom; Recruiting
Contact Person, Phone: 44-0124-2222-2222

Princess Royal Hospital at Hull and East Yorkshire NHS Trust, Hull, England HU8 9HE, United Kingdom; Recruiting
Contact Person, Phone: 44-0148-2701151

Leicester Royal Infirmary, Leicester, England LE1 5WW, United Kingdom; Recruiting
Contact Person, Phone: 44-011-6254-1414

Clatterbridge Centre for Oncology, Merseyside, England CH63 4JY, United Kingdom; Recruiting
Ernest Marshall, MD, Phone: 44-151-334-1155

Northampton General Hospital NHS Trust, Northampton, England NN1 5BD, United Kingdom; Recruiting
Contact Person, Phone: 44-016-0463-4700

Peterborough Hospitals Trust, Peterborough, England PE3 6DA, United Kingdom; Recruiting
Contact Person, Phone: 44-0173-387-4000

Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom; Recruiting
Contact Person, Phone: 44-114-226-5000

Airedale General Hospital, West Yorkshire, England BD20 6TD, United Kingdom; Recruiting
Contact Person, Phone: 44-015-356-2511

Western Infirmary, Glasgow, Scotland G11 6NT, United Kingdom; Recruiting
Contact Person, Phone: 44-0114-226-5000

Ysbyty Gwynedd, Bangor, Wales LL57 2PW, United Kingdom; Recruiting
Contact Person, Phone: 44-0124-838-4384

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2007
Last updated: April 1, 2010

Page last updated: February 07, 2013

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