Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized controlled trial of two adjunctive host-directed therapies in rifampin-resistant tuberculosis (DRTB-HDT).

This research study is looking into new ways to treat a specific kind of lung infection called rifampicin-resistant tuberculosis, sometimes called DRTB. This type of TB is harder to treat because standard medicines don't work as well. The study will test two additional medicines, given alongside existing treatments, to see if they can help patients get better. One medicine helps calm inflammation, and the other fights the infection. The main goals are to check if these new medicines are safe, if people can tolerate them well, and if they help improve lung health and get rid of the infection. Results for these main goals will be looked at after six months.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

The Aurum Institute, Quality Regulatory Clinical Ireland Limited, Quality Regulatory Clinical Ireland Limited

Enrolment target

Start

30 Jan 2025

Multidrug rezistant pulmonary tuberculosis

What is this study about?

This research study is about finding better ways to treat a serious lung infection called rifampicin-resistant tuberculosis, often shortened to DRTB. Normally, tuberculosis (TB) is treated with a combination of medicines. However, sometimes the TB germs become resistant to one of the main drugs, rifampicin, making the infection much harder to clear. This study specifically targets this tough type of TB.

The researchers are testing two new medicines to be given *in addition* to the usual treatment for rifampicin-resistant TB. Think of these as 'add-on' therapies. One medicine aims to reduce inflammation, which is the body's reaction to infection and can cause damage. The other medicine is designed to help fight the TB germs directly. The hope is that by combining these new approaches with existing treatments, patients will recover more effectively and have fewer problems.

The main things the study wants to find out are if these new medicines are safe to use, if people can take them without too many side effects, and if they actually help improve lung function and clear the infection. They will check on these important things after six months of treatment. They will also keep an eye on progress for up to 18 months, looking at things like how well the lungs are working and if the infection is completely gone.

Key takeaways

This study is for adults with a tough-to-treat lung infection called rifampicin-resistant TB.
It's testing two new 'add-on' medicines alongside standard treatment.
The goal is to see if these new medicines improve recovery and are safe.
Key results will be checked after 6 months, with follow-up for up to 18 months.
Participation involves regular clinic visits, tests, and taking study medicines.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part.

You would be considered for this study if you have been diagnosed with rifampicin-resistant tuberculosis that affects your lungs. This means the standard first-line treatments for TB are no longer fully effective for you.

There might be other specific health requirements or conditions that mean you can or cannot join the study, but these would be discussed in detail by the study team if you are interested.

Quick self-check

Are you 18 years old or older?
Do you have rifampicin-resistant tuberculosis that affects your lungs?
Are you typically able to attend regular clinic appointments for your medical care?
Are you comfortable potentially taking new types of medication as part of a study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive one of the two new study medicines or a 'control' treatment, in addition to your regular treatment for rifampicin-resistant tuberculosis. The study medicines involve taking tablets through your mouth. You wouldn't know which group you are in, and neither would your study doctor, to keep the results fair and unbiased.

You would have regular visits to the clinic for medical check-ups, tests, and to get your study medicine. These visits would allow the doctors to see how you are doing, monitor your health, and check for any side effects. You would have tests to measure your lung function and check for the presence of the TB infection.

The main period for assessing how well the treatment is working is 6 months. However, the study will continue to follow your progress for up to 18 months in total to see the long-term effects of the treatments. You would be told exactly what each visit involves and how long it would last.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as receiving new treatments that might help fight your rifampicin-resistant tuberculosis more effectively than current options alone. However, there's no guarantee the new medicines will work for you. Like all medicines, the study treatments might have side effects, which the study team would carefully monitor. You would be fully informed of any known risks before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

—
Romania

Common questions

What is rifampicin-resistant tuberculosis?

It's a type of lung infection caused by TB germs that have become resistant to one of the main antibiotics, rifampicin, making it harder to treat with standard medicines.

What kind of medicines are being tested?

The study is testing two additional medicines: one to help calm the body's reaction (anti-inflammatory) and another to help fight the infection directly (antimicrobial). These are given alongside your usual TB treatment.

How long will I be in the study?

The main treatment assessment is at 6 months, but you will be followed for up to 18 months in total to check long-term progress.

Will I know which treatment I'm getting?

No, you won't know if you're getting one of the new medicines or a comparison treatment, and neither will your study doctor. This is standard practice in research to ensure fair results.

What do they hope to achieve?

Researchers hope these new medicines will be safe, well-tolerated, and help improve lung health and clear the TB infection more effectively in people with rifampicin-resistant TB.