Can a smarter surgery and antibiotic combo cure joint infections for good?

NCT ID NCT06771050

Cure Sponsor: University of Newcastle, Australia Source: ClinicalTrials.gov ↗

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial compares different surgical and antibiotic approaches to treat infections in artificial hip and knee joints. It tests whether cleaning the joint while keeping the implant in place (DAIR) or replacing the joint entirely leads to better cure rates. It also examines whether adding the antibiotic rifampicin to standard care improves outcomes, and how long antibiotics should be taken after surgery. The goal is to find the most effective treatment combinations to cure these serious infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: surgery (DAIR or single-stage revision) and antibiotics (backbone antibiotics with or without rifampicin)
What this could lead to: If successful, this trial could identify the most effective surgical and antibiotic strategies to cure prosthetic joint infections, reducing the need for repeat surgeries and long-term disability.
What could go wrong: This is a large, pragmatic trial, but results may take years to emerge. Individual responses vary, and some treatments may not be suitable for all patients or infection types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. "Confirmed" or "Likely" Prosthetic joint infection of a large joint according to European Bone and Joint Infection Society (EBJIS) criteria (2021) 2. Physically present at participating hospital at time of eligibility assessment 3. "Current" prosthetic joint infection, meaning symptoms and/or signs of the PJI are present at the time of eligibility assessment. Exclusion Criteria: 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): 1. The index prosthetic joint is a shoulder, elbow, wrist or ankle. 2. Known previous participation in the randomised ROADMAP randomised platform for the index joint. 3. Known previous participation in the randomised ROADMAP platform for a joint other than the index joint within the 12 months prior to eligibility assessment 4. Treating clinician believes that death is imminent and inevitable. 5. Treatment is not with curative intent. 6. Patient is not classifiable into one of the three defined silos. 7. Patient is unlikely to be accessible for follow up over the 12 months following platform entry. 8. Treating team deems enrolment in the study is not in the best interests of the patient. To be included in any of the following Domains the participant must be eligible for the PLATFORM ( as listed above) and none of the platform-level exclusion criteria AND all of the domain-level inclusion and none of the domain-level exclusion criteria. 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. Surgical Strategy Domain: Late Acute Silo inclusion criteria Patient is in the Late Acute silo, meaning all of the following 3 criteria are met: 1. Onset of symptoms is \>30 days after implantation of the index joint 2. Treating team feel that either DAIR or revision is appropriate for this patient. 3. The infected prosthesis is a primary arthroplasty. Surgical Strategy Domain: Late Acute Silo exclusion criteria  1. Any previous episode of native joint septic arthritis or PJI in the index joint 2. A definitive DAIR has already occurred for this episode of infection. 3. A revision has already occurred for this episode of infection 4. Loosening or instability of any component of the prosthesis 5. Predicted inadequate soft tissue coverage for wound closure 6. One or more of the causative organisms is a fungus or a "difficult to treat" bacterium. 7. Treating team deems enrolment in this domain is not in the best interests of the patient. Antibiotic Choice Domain inclusion criteria 1. The time of eligibility assessment is between 48h and 7 days following initial surgical treatment. 2. One or more of the causative organisms is a Gram-positive of interest OR the infection is culture negative. Antibiotic Choice Domain exclusion criteria  1. Previous hypersensitivity reaction to rifampicin 2. The patient is receiving a concomitant medication with an expected clinically significant drug interaction with rifampicin, which cannot be ceased, substituted for an alternative agent, or mitigated by dose adjustment. 3. One or more causative Gram-positive organisms of interest have in-vitro evidence of resistance to rifampicin 4. Known pregnancy or breastfeeding 5. Treating team deems enrolment in this domain is not in the best interests of the patient. Antibiotic Duration Part A Domain inclusion criteria 1. A single stage revision procedure has been performed For the purposes of this domain, the definition of a single stage revision procedure is as follows: A one-stage revision means: • Arthrotomy • Removal of all prosthetic components • Comprehensive synovectomy • Placement of "definitive" new components * could be primary or revision components • With no plans for a second stage operation Additional recommended elements (not part of definition, but considered 'ideal' elements of this procedure): * Removal of all loose cement; well-fixed cement may be retained. * Double set up (using a separate set of sterile instruments and drapes for the reimplantation) Antibiotic Duration Part A Domain exclusion criteria Patients will be excluded from this domain if, at the time of eligibility assessment, they have any of the following:  1. Any causative organism is a fungus or a 'difficult-to-treat' bacterium at the time of platform entry 2. Treating team deems enrolment in this domain is not in the best interests of the patient 3. The single stage revision was \>7 days ago 4. Patient no longer willing to participate in the domain Antibiotic Duration Part B Domain Eligibility assessment and allocation reveal will be performed at day 7 (+/- 3 days) from the time of the reimplantation operation - i.e. between 4 and 10 days following the reimplantation operation. The purpose of this time frame is to confirmation of negative reimplantation cultures. Antibiotic Duration Part B Domain inclusion criteria 1. A two-stage revision procedure has been performed For the purposes of this domain, the definition of two-stage revision and reimplantation procedures are defined as follows: A two-stage revision means: • Removal of all existing prosthetic components (including metal, ceramic, polyethylene) and any loose cement * Placement of a temporary prosthesis or spacer with the intention to replace this at a later time point with a permanent prosthesis * The intention to subsequently replace of the temporary spacer with a definitive prosthesis at a reimplantation operation in the future Additional recommended elements (not part of definition, but encouraged): • Use of antibiotic-loaded cement as the spacer * Use of an articulating spacer which is capable of withstanding weight-bearing A reimplantation procedure as the second stage of a two-stage revision means: • Removal of the temporary prosthesis and all associated cement * Implantation of a new prosthesis; considered the 'destination prosthesis' 2. The infected prosthesis was a primary (not revision) arthroplasty 3. At least 6 weeks of antibiotics have been received following the first stage revision, intended as treatment of the index infection 4. The reimplantation operation was done 4-10 days ago Antibiotic Duration Part B Domain exclusion criteria 1. \>6 months has passed since platform entry 2. One or more of the causative organisms is a fungus or a 'difficult-to-treat' bacterium 3. No perioperative tissue or fluid cultures were collected at the reimplantation operation 4. Perioperative cultures collected at reimplantation grow a significant organism (s) 5. Long-term antibiotic suppressive therapy is planned following the reimplantation operation 6. Treating team deems enrolment in this domain is not in the best interests of the patient 7. Patient no longer willing to participate in the domain

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Conditions

The condition(s) this trial relates to.

periprosthetic joint infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Large joint prosthetic joint infections Prosthetic joint infections of hip Prosthetic joint infections of knee

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

43 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Bankstown- Lidcombe Hospital
NOT_YET_RECRUITING

Bankstown, New South Wales, 2200, Australia
Blacktown Hospital
RECRUITING

Blacktown, New South Wales, 2148, Australia
Calvary Adelaide Private Hospital
RECRUITING

Adelaide, South Australia, 5000, Australia
Campbelltown Hospital
RECRUITING

Campbelltown, New South Wales, 2560, Australia
Counties Manukau (Middlemore Hospital)
RECRUITING

Mangere East, Auckland, 2025, New Zealand
Dandenong/Monash Hospital
NOT_YET_RECRUITING

Dandenong, Victoria, 3175, Australia
Eastern Health
RECRUITING

Box Hill, Victoria, 3128, Australia
Fiona Stanley Hospital
RECRUITING

Murdoch, Western AustraliaA, 6150, Australia
Flinders Medical Centre
RECRUITING

Bedford Park, South Australia, 5042, Australia
Gold Coast University Hospital
RECRUITING

Southport, Queensland, 4215, Australia
John Hunter Hospital
RECRUITING

New Lambton, New South Wales, 2305, Australia
Latrobe Regional Hospital
RECRUITING

Traralgon, Victoria, 3844, Australia
Launceston General Hospital
NOT_YET_RECRUITING

Launceston, Tasmania, 7250, Australia
Liverpool Hospital
RECRUITING

Liverpool, New South Wales, 2170, Australia
Logan Beaudesert Hospital
RECRUITING

Beaudesert, Queensland, 4285, Australia
Mater Hospital Brisbane
RECRUITING

South Brisbane, Queensland, 4101, Australia
Mater Hospital Sydney ST Vincents Network
NOT_YET_RECRUITING

North Sydney, New South Wales, 2060, Australia
Nepean Hospital
RECRUITING

Kingswood, New South Wales, 2747, Australia
Northern health
RECRUITING

Epping, Victoria, 3076, Australia
Prince Charles Hospital
NOT_YET_RECRUITING

Chermside, Queensland, 4032, Australia
Prince of Wales Hospital
RECRUITING

Randwick, New South Wales, 2031, Australia
Princess Alexandra Hospital
RECRUITING

Woolloongabba, Queensland, 4102, Australia
Ramsay Research C/O Lake Macquarie Private Hospital
RECRUITING

Gateshead, New South Wales, 2290, Australia
Redcliffe Hospital
NOT_YET_RECRUITING

Redcliffe, Queensland, 4020, Australia
Royal Adelaide Hospital
RECRUITING

Adelaide, South Australia, 5011, Australia
Royal Brisbane and Women's Hospital
RECRUITING

Herston, Queensland, 4029, Australia
Royal Perth Hospital
RECRUITING

Perth, Western Australia, 6000, Australia
Royal Prince Alfred Hospital
RECRUITING

Camperdown, New South Wales, 2747, Australia
Sir Charles Gairdner Hospital
RECRUITING

Nedlands, Western Australia, 6009, Australia
St George
RECRUITING

Kogarah, New South Wales, 2217, Australia
St Vincents
RECRUITING

Fitzroy, Victoria, 3065, Australia
Sunshine Coast University Hospital
NOT_YET_RECRUITING

Birtinya, Queensland, 4575, Australia
Sutherland Hospital
RECRUITING

Caringbah, New South Wales, 2229, Australia
Te Toka Tumai (Auckland Hospital)
RECRUITING

Grafton, Auckland, 1023, New Zealand

Contact Email: •••••@•••••
The Alfred Hospital
RECRUITING

Melbourne, Victoria, 3011, Australia
The Canberra Hospital
NOT_YET_RECRUITING

Garran, Australian Capital Territory, 2605, Australia
The Queen Elizabeth Hospital
RECRUITING

Woodville, South Australia, 5011, Australia
Toowoomba Hospital- Darling Downs Health
RECRUITING

Toowoomba, Queensland, 4350, Australia
Townsville Hospital and Health Service
NOT_YET_RECRUITING

Douglas, Queensland, 4814, Australia
University Hospital Geelong
NOT_YET_RECRUITING

Geelong, Victoria, 3220, Australia
Waitemata (North Shore Hospital)
RECRUITING

Takapuna, Auckland, 0620, New Zealand

Contact Email: •••••@•••••
Western Health
RECRUITING

Footscray, Victoria, 3011, Australia
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia

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