Randomised Arthroplasty Infection Worldwide Multidomain Adaptive Platform (ROADMAP) Trial

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

2,500

Participants

Timeline

Start Date

March 26, 2025

Primary Completion Date

February 18, 2028

Study Completion Date

December 31, 2029

Conditions
Prosthetic Joint Infections of HipProsthetic Joint Infections of KneeLarge Joint Prosthetic Joint Infections
Interventions
PROCEDURE

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."

DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (31)

2060

Mater Hospital Sydney ST Vincents Network, North Sydney

2145

Westmead Hospital, Westmead

2148

Blacktown Hospital, Blacktown

2170

Liverpool Hospital, Liverpool

2217

St George, Kogarah

2305

John Hunter Hospital, New Lambton

2605

The Canberra Hospital, Garran

2747

Royal Prince Alfred Hospital, Camperdown

Nepean Hospital, Kingswood

3011

Western Health, Footscray

The Alfred Hospital, Melbourne

3065

St Vincents, Fitzroy

3076

Northern health, Epping

3128

Eastern Health, Box Hill

Epworth Hospital, Box Hill

3175

Dandenong/Monash Hospital, Dandenong

3220

University Hospital Geelong, Geelong

4020

Redcliffe Hospital, Redcliffe

4029

Royal Brisbane and Women's Hospital, Herston

4032

Prince Charles Hospital, Chermside

4101

Mater Hospital Brisbane, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4215

Gold Coast University Hospital, Southport

4575

Sunshine Coast University Hospital, Birtinya

4814

Townsville Hospital and Health Service, Douglas

5000

Calvary Adelaide Private Hospital, Adelaide

5011

Royal Adelaide Hospital, Adelaide

The Queen Elizabeth Hospital, Woodville

5042

Flinders Medical Centre, Bedford Park

6000

Royal Perth Hospital, Perth

6150

Fiona Stanley Hospital, Murdoch

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hunter Medical Research Institute (HMRI)

UNKNOWN

collaborator

The University of Western Australia

OTHER

collaborator

Michael Garron Hospital

OTHER

collaborator

Aotearoa Clinical Trials

UNKNOWN

collaborator

Exeter Orthopaedic Trial unit

UNKNOWN

collaborator

University of Sydney

OTHER

collaborator

University of Melbourne

OTHER

collaborator

The Peter Doherty Institute for Infection and Immunity

OTHER

lead

University of Newcastle, Australia

OTHER