Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107081
Status:
TERMINATED
Last Update Posted:
2020-11-02
First Post:
2005-04-04
Brief Title:
Low-risk Fever and Neutropenia in Children With Cancer Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
Sponsor:
Swiss Pediatric Oncology Group
Organization:
Swiss Pediatric Oncology Group
Study Overview
Official Title:
A Prospective Multi-Center Study on Pediatric Patients With Fever in Severe Chemotherapy Induced Neutropenia Including a Randomized Comparison of Outpatient Management and Oral Antimicrobial Therapy Versus Inpatient Management and Intravenous Antimicrobial Therapy in a Subgroup With Low Risk of Adverse Events Low-Risk Subgroup Study
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual goal for interventional part not achievable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether in children with cancer presenting with fever in severe chemotherapy-induced neutropenia at low risk for medical complications oral antibiotics in an outpatient setting after an initial phase of intravenous antibiotics and in-hospital observation for 8 to 22 hours is not inferior as to safety and efficacy compared to continued intravenous antibiotics given in-hospital
Detailed Description:
Details on antimicrobial therapy
At presentation with FN fever and neutropenia and during an initial inpatient observation period of 8 to 22 hours empirical intravenous broad-spectrum antibiotics are given Type and dosage are chosen by the treating physician
Patients randomized to continued intravenous antibiotics continue with these antibiotics
Patients randomized to oral antibiotics receive a combination of oral ciprofloxacin 25 to 30 mgkgday top dose 1500 mgday plus oral amoxicillin 65 to 80 mgkgday top dose 2250 mgday both given in two doses per day
In both groups the study gives guidelines for certain situations and rules for other situations when to change and when to stop antibiotics
Details on clinical and laboratory controls
During antibiotic therapy patients are seen daily either as inpatients or as outpatients according to randomization Complete blood counts are performed at least every second day
After stopping antibiotic therapy and until resolution of severe neutropenia if applicable patients are seen every other day with a complete blood count
Patients randomized to outpatient management have the possibility to contact at any time of the day and night a pediatric oncologist in case of problems in order to discuss necessity for emergency control andor rehospitalization
At presentation with FN fever and neutropenia and during an initial inpatient observation period of 8 to 22 hours empirical intravenous broad-spectrum antibiotics are given Type and dosage are chosen by the treating physician
Patients randomized to continued intravenous antibiotics continue with these antibiotics
Patients randomized to oral antibiotics receive a combination of oral ciprofloxacin 25 to 30 mgkgday top dose 1500 mgday plus oral amoxicillin 65 to 80 mgkgday top dose 2250 mgday both given in two doses per day
In both groups the study gives guidelines for certain situations and rules for other situations when to change and when to stop antibiotics
Details on clinical and laboratory controls
During antibiotic therapy patients are seen daily either as inpatients or as outpatients according to randomization Complete blood counts are performed at least every second day
After stopping antibiotic therapy and until resolution of severe neutropenia if applicable patients are seen every other day with a complete blood count
Patients randomized to outpatient management have the possibility to contact at any time of the day and night a pediatric oncologist in case of problems in order to discuss necessity for emergency control andor rehospitalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OCS - 01466-02-2004 | None | None | None |
| Umbrella Network Trial 20043 | None | None | None |