Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445497
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2007-03-07
Brief Title:
Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia
Sponsor:
Clatterbridge Centre for Oncology
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
OBJECTIVES
Identify cancer patients who are low-risk inpatients and meet criteria for early discharge ie symptomatic improvement and temperature 378C 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 ie symptomatic improvement irrespective of neutrophil recovery temperature 378 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 37C for 24 hours and absolute neutrophil count 500mm³ 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
Identify cancer patients who are low-risk inpatients and meet criteria for early discharge ie symptomatic improvement and temperature 378C 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 ie symptomatic improvement irrespective of neutrophil recovery temperature 378 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 37C for 24 hours and absolute neutrophil count 500mm³ 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000533828 | REGISTRY | None | None |
| CRUK-ORANGE | None | None | None |
| ISRCTN18467252 | None | None | None |
| EU-20707 | Registry Identifier | PDQ Physician Data Query | None |