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]
- 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
- 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.
Allocation: Randomized, Primary Purpose: Supportive Care
Total number of days of hospitalization (including unplanned readmission) (randomized patients)
Ernest Marshall, MD
Clatterbridge Centre for Oncology