Randomised Arthroplasty Infection Worldwide Multidomain Adaptive Platform (ROADMAP) Trial
ROADMAP
The RandOmised Arthroplasty Infection worlDwide Multidomain Adaptive Platform (ROADMAP) Trial
3 other identifiers
interventional
2,500
1 country
31
Brief Summary
Artificial joint infections are treated with different types of antibiotics and surgery. The ROADMAP study aims to find out which treatments currently used work best in regards to surgery, antibiotic choice as well as the time taking antibiotics. The study will compare different treatments against each other to see which treatment or treatment combination works to provide the best outcome and cure at 12 months. The study will focus on adults with infected artificial hips and knees. ROADMAP trial looks at normal good clinical care and does not ask any person taking part in the study to have any extra tests or treatments. If a person takes part in the study they will:
- Sign a consent form
- Give permission for infection and treatment information to be collected and entered into a central ROADMAP specific database and a separate registry of prosthetic joint infection patients. This medical information will include participants medical history, test results and treatment they received. The study will also collect information about medical care and how the participant is feeling at Day 100 and Day 365 (1 year) after starting the study. There are several different study parts. Each part focuses on research focus areas called domains. ROADMAP has 3 different domains; 1. Surgical, 2. Antibiotic choice and 3. Antibiotic Duration domains. Not every hospital is taking part in all 3 domains and if someone chooses to participate they do not have to participate in all domains. Specific domain details are:
- Surgical Treatment Domain This domain will find out if it is better to do an operation to clean out the infection but keep the artificial joint in place (this is called a Debridement, Antibiotics and Implant Retention operation (DAIR)) or to clean out the infection and swap the artificial joint out for a new one (this is called a "revision" operation).
- Antibiotic Choice Domain Many different microorganisms (germs) can cause artificial joint infections and many different antibiotics are used to fight infections. ROADMAP will look at different antibiotics commonly used to treat artificial joint infection. This domain will focus on an antibiotic called rifampicin (also sometimes known as rifampin) as it is often added to other antibiotics to help treat artificial joint infections. Rifampicin is not a new antibiotic but it is not clear if treatment cure rates are better if it is added.
- Antibiotic Duration Domain Antibiotic treatment times are the focus of this domain as it is not clear how long someone should take antibiotics when revision surgery is used to treat artificial joint infection. To show what antibiotic time period is best for treatment and cure people who have had revision surgery participating in this domain will receive either "standard" or "extended" duration of antibiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2025
Longer than P75 for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2025
CompletedFirst Posted
Study publicly available on registry
January 13, 2025
CompletedStudy Start
First participant enrolled
March 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
March 10, 2025
March 1, 2025
2.9 years
January 7, 2025
March 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment success at 12 months
The primary endpoint for all cells and domains will be treatment success at 12 months, defined as ALL FOUR OF: 1. Patient is alive. 2. Clinical cure = no clinical or microbiological evidence of ongoing infection in the index joint 3. The patient is no longer taking antibiotics for the index joint. 4. The destination prosthesis is still in place. The primary endpoint is determined through a search of hospital databases for a record of participant's death, or follow-up contact with participant's community healthcare provider, or follow-up contact with patient or their nominated carer, or linkage with death registries. The preferred method is through direct face to face clinic visit. However, phone contact with the patient may occur. In addition, any or all of the four components of the primary endpoint can be derived from external data such as GP records or specialist letters.
up to 13 months (with a window of up to 13 months i.e. 365 to 395 days) after platform entry.
Secondary Outcomes (11)
A "desirability of outcome ranking" DOOR
Platform entry until day 265
Patient-reported joint function (Oxford hip or knee score) at 12 months after platform entry.
platform entry until day 365
Patient-reported quality of life (EuroQol-5 Dimensions-5 Levels (EQ5D5L)) at 12 months after platform entry.
Platform entry until day 365
Cost effectiveness over the first 12 months after platform entry.
From platform entry until day 365
All-cause mortality at 12 months after platform entry
From platform entry until day 365
- +6 more secondary outcomes
Study Arms (4)
1. SURGICAL DOMAIN: Late Acute Silo
ACTIVE COMPARATORSurgical Domain comparing outcomes of surgical strategies - Debridement and implant retention (DAIR) versus Revision arthroplasty (either one stage or two stage at the discretion of the treating surgeon)
2. ANTIBIOTIC CHOICE DOMAIN
ACTIVE COMPARATORBackbone therapy alone (active comparator) versus Backbone antibiotic therapy plus Rifampicin.
3. ANTIBIOTIC DURATION DOMAIN Part A - Single Stage Revision
ACTIVE COMPARATORLength of antibiotic course duration after a single stage revision, short course (6 weeks) versus long course (12 weeks).
4. ANTIBIOTIC DURATION DOMAIN Part B - Two Stage Revision
ACTIVE COMPARATORNo extended antibiotic prophylaxis versus extended antibiotic prophylaxis following a two-stage revision.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- "Confirmed" or "Likely" Prosthetic joint infection of a large joint according to European Bone and Joint Infection Society (EBJIS) criteria (2021)
- Physically present at participating hospital at time of eligibility assessment
- "Current" prosthetic joint infection, meaning symptoms and/or signs of the PJI are present at the time of eligibility assessment.
You may not qualify if:
- Potentially eligible participants meeting any of the following criteria at the time of eligibility assessment for platform entry will be excluded from the randomised platform (but may still participate in the registry):
- The index prosthetic joint is a shoulder, elbow, wrist or ankle.
- Known previous participation in the randomised ROADMAP randomised platform for the index joint.
- Known previous participation in the randomised ROADMAP platform for a joint other than the index joint within the 12 months prior to eligibility assessment
- Treating clinician believes that death is imminent and inevitable.
- Treatment is not with curative intent.
- Patient is not classifiable into one of the three defined silos.
- Patient is unlikely to be accessible for follow up over the 12 months following platform entry.
- Treating team deems enrolment in the study is not in the best interests of the patient.
- Domain-specific eligibility criteria Each domain may have additional criteria for eligibility. Participants who fulfil the above criteria will be assessed for enrolment into all domains active at a participating site. At least 2 interventions (which may include standard of care) within a domain must be available to an eligible participant in order for that participant to enter the domain. The minimum number of interventions within a domain is two. The availability of interventions within domains will be region- and site-specific, although the default position is that all interventions within a domain will be available at all sites.
- Patient is in the Late Acute silo, meaning all of the following 3 criteria are met:
- Onset of symptoms is \>30 days after implantation of the index joint
- Treating team feel that either DAIR or revision is appropriate for this patient.
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- Any previous episode of native joint septic arthritis or PJI in the index joint
- +54 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Newcastle, Australialead
- Hunter Medical Research Institute (HMRI)collaborator
- The University of Western Australiacollaborator
- Michael Garron Hospitalcollaborator
- Aotearoa Clinical Trialscollaborator
- Exeter Orthopaedic Trial unitcollaborator
- University of Sydneycollaborator
- University of Melbournecollaborator
- The Peter Doherty Institute for Infection and Immunitycollaborator
Study Sites (31)
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2747, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
St George
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Mater Hospital Sydney ST Vincents Network
North Sydney, New South Wales, 2060, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Townsville Hospital and Health Service
Douglas, Queensland, 4814, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Redcliffe Hospital
Redcliffe, Queensland, 4020, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Calvary Adelaide Private Hospital
Adelaide, South Australia, 5000, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5011, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Eastern Health
Box Hill, Victoria, 3128, Australia
Epworth Hospital
Box Hill, Victoria, 3128, Australia
Dandenong/Monash Hospital
Dandenong, Victoria, 3175, Australia
Northern health
Epping, Victoria, 3076, Australia
St Vincents
Fitzroy, Victoria, 3065, Australia
Western Health
Footscray, Victoria, 3011, Australia
University Hospital Geelong
Geelong, Victoria, 3220, Australia
The Alfred Hospital
Melbourne, Victoria, 3011, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Fiona Stanley Hospital
Murdoch, Western AustraliaA, 6150, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joshua S Davis. Co-chief Investigator, infectious diseases Specialist
University of Newcastle, Menzies Institute, Hunter Medical Research Institute, Hunter New England Health
- STUDY DIRECTOR
Laurens Manning, Co-chief Investigator, infectious diseases Specialist
The University of Western Australia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This will be an open-label study unless otherwise specified in a domain-specific appendix. For the overall data and results, only specified members of the statistical analytical team and Data and Safety Monitoring Committee (DSMC) will have access to unblinded results, with other trial investigators and staff remaining blinded to the aggregate results until completion of final analysis for a domain or cell.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2025
First Posted
January 13, 2025
Study Start
March 26, 2025
Primary Completion (Estimated)
February 18, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
March 10, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
Study data can be requested for future research through contacting the study team and requesting access. The Global Clinical Trial Management Team will review applications and approve or decline applications based on researcher supplied information. The ROADMAP trial Has in development a Publication policy and also a data access policy which protects the data prior to publication in open sources.