Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538053
Status:
RECRUITING
Last Update Posted:
2023-08-09
First Post:
2020-07-14
Brief Title:
BonE and Joint Infections - Simplifying Treatment in Children Trial
Sponsor:
Murdoch Childrens Research Institute
Organization:
Murdoch Childrens Research Institute
Study Overview
Official Title:
BonE and Joint Infections - Simplifying Treatment in Children Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
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:
BEST
Brief Summary:
This is a multi- centre trial of children with bone and joint infections BJIs at eight major paediatric hospitals in Australia and New Zealand The primary objective is to establish if in children with acute uncomplicated BJIs entirely oral antibiotic treatment is not inferior to initial intravenous IV treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation Children will be randomly allocated to the entirely oral antibiotic group or the standard treatment group
Detailed Description:
Children with acute onset BJIs who present to the participating sites will be enrolled into the trial if eligible see eligibility criteria and randomly allocated into two groups Children in the standard treatment group will receive standard treatment for BJIs which consists of IV antibiotics for 1-7 days followed by 3 weeks of oral antibiotics Children in the entirely oral treatment group will receive high dose oral antibiotics followed by the standard dose of oral antibiotics for 3 weeks The outcomes of children in each of the two groups will be compared to determine whether BJIs can be treated without needing a course of IV antibiotics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None