2,500
Participants
Start Date
March 26, 2025
Primary Completion Date
February 18, 2028
Study Completion Date
December 31, 2029
Debridement and Implant Retention (DAIR)
"Intervention 1: DAIR- cleaning of infected joint including irrigation, debridement and exchange of modular components (those not fixed to bone) with implant retention.~Intervention 2: Single stage revision - cleaning of infected joint including irrigation, removal and placement of definitive new components which could be primary or revision components."
Antibiotic Choice
"No intervention: Backbone antibiotic therapy only depends on the organism and is detailed in the protocol.~Intervention: Backbone antibiotic therapy plus rifampicin. Dosage 600-900mg per day orally for as long as oral antibiotic treatment continues, but not more than 12 weeks. Prescribed according to local recommended practices and dosed as per local therapeutic guidelines."
Antibiotic duration Part A - Single stage revision
"Intervention Arm: Short course 6-week (42 +/- 7 days) antibiotic course - combined intravenous and oral with antibiotic choice according to organism and patient tolerability factors.~Intervention Arm: Long course 12- week (84 +/- 7 days) antibiotic course - combined intravenous and oral with antibiotic choice according to organism and patient tolerability factors."
Antibiotic Duration Part B - Two stage revision
"Intervention Arm: Extended prophylaxis for 12 weeks after the 2nd stage revision surgery.~Intervention Arm: No extended antibiotic prophylaxis after the 2nd stage revision surgery.~Antibiotic choice by treating team with reference to the original causative organism(s), susceptibility and patient tolerability."
Mater Hospital Sydney ST Vincents Network, North Sydney
Westmead Hospital, Westmead
Blacktown Hospital, Blacktown
Liverpool Hospital, Liverpool
St George, Kogarah
John Hunter Hospital, New Lambton
The Canberra Hospital, Garran
Royal Prince Alfred Hospital, Camperdown
Nepean Hospital, Kingswood
Western Health, Footscray
The Alfred Hospital, Melbourne
St Vincents, Fitzroy
Northern health, Epping
Eastern Health, Box Hill
Epworth Hospital, Box Hill
Dandenong/Monash Hospital, Dandenong
University Hospital Geelong, Geelong
Redcliffe Hospital, Redcliffe
Royal Brisbane and Women's Hospital, Herston
Prince Charles Hospital, Chermside
Mater Hospital Brisbane, South Brisbane
Princess Alexandra Hospital, Woolloongabba
Gold Coast University Hospital, Southport
Sunshine Coast University Hospital, Birtinya
Townsville Hospital and Health Service, Douglas
Calvary Adelaide Private Hospital, Adelaide
Royal Adelaide Hospital, Adelaide
The Queen Elizabeth Hospital, Woodville
Flinders Medical Centre, Bedford Park
Royal Perth Hospital, Perth
Fiona Stanley Hospital, Murdoch
Collaborators (1)
Hunter Medical Research Institute (HMRI)
UNKNOWN
The University of Western Australia
OTHER
Michael Garron Hospital
OTHER
Aotearoa Clinical Trials
UNKNOWN
Exeter Orthopaedic Trial unit
UNKNOWN
University of Sydney
OTHER
University of Melbourne
OTHER
The Peter Doherty Institute for Infection and Immunity
OTHER
University of Newcastle, Australia
OTHER