Clinical trial · Interventional
Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia
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]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amoxicillin-clavulanate potassium | Drug | — | UNRESOLVED |
| ciprofloxacin | Drug | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Total number of days of hospitalization (including unplanned readmission) (randomized patients)
- measure
- Incidence of serious adverse events (randomized and registered patients)
Secondary outcomes (5)
- measure
- Incidence of treatment failure as defined by the necessity for change in antibiotic therapy (randomized and registered patients)
- measure
- Incidence of unplanned readmissions (randomized patients)
- measure
- Patient acceptability of randomized discharge policy as measured by Health Questionnaire, Cancer Worries Inventory Booklet, and Patient Daily Diary (randomized patients)
- measure
- Toxicity attributed to oral antibiotic therapy as measured by NCI CTCAE v3.0 (randomized and registered patients)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available