Patient Information

A randomised clinical trial (RCT) is a research study where every person that participates is randomly assigned to either a treatment group or a control group, with the same information collected about treatment and outcomes for both groups and then compared to see if there is a difference between the groups.

RTC’s are performed in a controlled setting, such as a clinical hospital, and target a specific disease.

The trial outcome is measured by an event at a specific timepoint, such as a cure or no cure at 3 months and at 12 months or more. RTC’s are commonly used to compare the effects of drugs such as antibiotics and also compare treatments such as type of surgery.

In ROADMAP, we will be comparing antibiotic and surgical treatments against each other to find out which treatment might work best. We will also be looking at outcomes at 3 and 12 month timepoints to assess outcomes at an early and also later timepoint.

ROADMAP is a trial that adapts as we proceed. Once one treatment is found to be clearly better than another treatment, patients will continue to receive the better treatment, and the poorer treatment is removed from the trial.

ROADMAP will have a lot of hospital trial sites around the world, which will help to include a large number of patient participants and allow us to reach study conclusions as quickly as possible.

As study participant data is collected, trial statisticians will analyse the data in near real-time rather than waiting for years to analyse data at the end of a trial. Adaptive trials can produce outcomes quicker, meaning that changes to treatments techniques can happen sooner, improving care for all patients quicker.

ROADMAP will also have an independent data and safety monitoring committee reviewing the trial data and analyses to ensure patient safety is maintained and that results are acted upon in a timely and appropriate manner.

The advantages of Adaptive trials over other trial designs are that:

With an adaptive design, regular data analysis timepoints are built into the trial and changes can be made quickly to improve the trial comparisons or to act on trial findings if one treatment is found to be better or worse than the other.

People that decide to participate in ROADMAP, will be asked to give consent to participate in ROADMAP by signing a form that explains:

The participant will also be given a copy of the Information and Consent form to keep.

Once consent has been given, the participant’s medical information will be assessed for eligibility criteria to ensure it is safe to participate in the ROADMAP study domains that they have given consent to be a part of. If eligible, the participant will then be randomly allocated to a treatment arm for the domain or domains of the trial.

ROADMAP has three different treatment domains. To learn more about each domain, please see the explanatory videos here. Each domain has certain eligibility.

Participating in a research study is a free choice that each person can make. If the person asked to participate chooses not to participate, their decision will be respected and they will be given the usual and standard treatments that are used in the hospital or clinic they are attending. In some cases, this usual care and treatment may actually be the same treatments they would have received if they were in the study.

It is also important to know that people consenting to participate in ROADMAP can change their decision at any time and withdraw from the trial without giving a reason. They can withdraw from the study at any time, by notifying a member of the research team. Choosing to participate in the ROADMAP trial or NOT, or withdrawing at a later date will not affect the care and treatment given, they will be offered the usual care and treatments offered at the hospital or clinic they are attending.

If they do withdraw, they will have two options:
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1. Withdraw from the study treatment ONLY. If they choose this option, they will receive standard treatment, and the ROADMAP study team will continue to collect data from them for 12 months.

2. Withdraw from the study treatment and further data collection. In this case the ROADMAP team will keep any information all data collected about them up to withdrawal date. If they are not comfortable with this, then they should not join the study.

The treating team will choose the antibiotic, or combination of antibiotics that are best suited to the participant’s particular infection.  The antibiotic(s) chosen are based on what germs are causing the infection, what antibiotics the laboratory tells us will help kill the germs, medical history of the participant and also whether they have any antibiotic allergies or preferences.

In ROADMAP, each participant will be given an antibiotic or group of antibiotics called the “backbone antibiotics”. Some participants will be given the “backbone antibiotics” plus an extra antibiotic called “rifampicin”. Commonly used backbone antibiotics include vancomycin, cefazolin and flucloxacillin but there are many others as well.

In this domain, ROADMAP is testing whether adding the extra antibiotic works better than just the backbone antibiotics alone to cure the infection.

There are no costs associated with participating in ROADMAP, nor is there any payment to participants. All medications and treatments required as part of the study will be provided to you as free of charge within public hospital systems.  

If the ROADMAP site is a private hospital and your treatment is offered under a private medical arrangement, then any costs applied are as part of a private agreement between the participant, their treating team and the private facility. ROADMAP will not add any additional fee.

Complaints about the conduct of the study or any of the study team can be made via the links below in the region they are living.  Complaints can also be made by contacting the Global management team via email  TMG@roadmaptrial.com

People have the right to make a complaint and can be assured that in making a complaint it will not affect any care or treatment that they are receiving.

For contact details to make a complaint please click on the relevant country:

Australia
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact:

Hunter New England Human Research Ethics Committee
HREC Executive Officer Manager, Research Ethics
Telephone 02 49214140
Email HNELHD-ResearchOffice@health.nsw.gov.au
ROADMAP Reference 2024/ETH00569
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Canada
TBA
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New Zealand
TBA
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United Kingdom
TBA

ROADMAP participants will be given a participant card with the study team details to keep at all times. The contact details listed on the card can be used to contact the study team at any time if they have any questions or concerns.

The ROADMAP research team will collect information from the participants medical records and for this reason basic contact details and identifiers will be recorded by the site team as part of their normal systems. However, the ROADMAP specific information provided to the main platform database will be coded to protect your privacy and identity.

Specific consent will be asked to be provided if the participant chooses to be included in a registry of people experiencing PJI. Please see Data linkage and registry below for more information. The information collected will include medical history, blood test results and details of the treatment that was received.

The participant will also be asked to complete a quality-of-life short survey at the start of participation and at the end of follow up period at 12 months. Similar information will be collected at two different timepoints (90-100 days; and 12 months).

Information collected from medical records will be focused on any treatments related to the PJI. This information may be collected from the participant whilst in the hospital or by a phone call after 90 days and 12 months.

Data Linkage
Participants will be asked for permission to link their identifiable study information to existing datasets, such as hospital records, medication registries, emergency department, and registries of births, deaths and marriages, to allow longer follow-up.

Registry
As part of the study, ROADMAP would like to collect data for a registry of patients with prosthetic joint infections. The registry will be used to improve current practice and quality of care. All of the information collected as part of the Registry is from data that is routinely collected as part of your routine care and will be collected from your medical notes.

Any identifiable information about the participant collected with this study will remain confidential and will comply with all relevant country specific privacy legislation. If required, the regulatory authorities and an authorised representative of the trial Sponsor may require access to personal information to ensure the clinical trial is compliant with the regulatory and safety requirements.

The length of storage for identifiers and privacy legislations varies from country to country as indicated below:

The study team will use participant details to contact them for the follow-up checks, and to send information about the study results. Data collected for the study will be stored in a secure database in accordance with the relevant regional privacy laws.

Participants name, address, and date of birth may be used to link study information to existing datasets, such as hospital records, medications, emergency department, and registries of births, deaths, and marriages. This will allow longer follow-up of outcomes, like readmission to hospital, without us needing to contact the participant directly.

This information will be kept strictly confidential and only used for the study or for future research related to artificial joint infections and related conditions. The only people allowed to look at information that could identify the participant (name, address, date of birth) will be the participants doctors, study staff, the data co-ordinator from the University of Newcastle, the unit who performs the linkage, and regulatory authorities who may want to check the study is carried out correctly.

For further information about Data Collection and Storage, and Data Linkage please select from the links below.

See link to Data Collection and Storage Document

See link to Data Linkage Document

The bacteria grown from participant infection samples will be stored in a sample biobank as identified organisms rather than a participant identifiable sample. Studies on the bacteria will help researchers better understand how the bacteria make people sick and how the bacteria respond to antibiotic treatments. No other samples (e.g. blood or urine) will be collected or stored for this study unless the participant is participating in a sub-study, which will be detailed in a separate information and consent form.

All the treatments in ROADMAP are already widely used in normal care. The risks of being in the study are low.  Any person participating in the study will be or have been treated with one or more operations and a course of antibiotics, whether they take part in the study or not.

If randomised to receive the extra antibiotic, rifampicin, in addition to other antibiotics there is a small chance of side effects. Most side effects are mild, such as nausea, diarrhoea, or rash. Rarely, more severe side effects might happen, such as liver or kidney inflammation, but these usually get better when the treatment is stopped. Rifampicin can also interact with other medications; however, all ROADMAP treatments will be assessed by the participants doctor and study team and will be carefully checked for interactions and safety based on the participants medical record and individual information and preferences.

Long courses of antibiotics may cause more side effects than shorter courses, including diarrhoea, secondary infections, and complications of intravenous (IV) lines however, any side effect can be managed by the treating team and if necessary, antibiotics can be changed, the dosage reduced or stopped to reduce or limit any side effect.

Any surgery has risks associated with it and can be low to high based on the participants medical history. These risks would occur whether participating in the study or NOT as surgery is part of standard treatment practice for PJI.  ROADMAP surgical risks are managed by the participants doctors, and participation in the surgical domain would only occur if the treating team deemed it safe. Risks can include wound infection, bleeding, and nerve injury. These risks may be higher if you need two operations (two-stage revision) rather than one.

There may not be any benefit from participating in ROADMAP, but it is possible the treatment participants receive may work better, or more quickly, or be more convenient than treatment they would have received. Research like this also helps to continually improve the treatments and care provided to all patients now and in the future.

This study is known as an “adaptive clinical trial”. In this type of study, the researchers look at the results as the study goes on rather than just at the end. If the results show any of the treatments do not work as well as others, they will be dropped from the study. This means that after the study has been running for a while, there may be better odds of participants getting a better treatment.

New information about the treatments being studied may become available during the course of the study. Participants will be kept informed of any significant new findings that may affect their willingness to continue in the study. If they wish to withdraw from the study once it has started, they can do so at any time without having to give a reason.