AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomised, prospective phase II study of pharmacokinetics and safety aspects of higher doses of rifampicin and pyrazinamide in a shortened treatment of mild-to-moderate tuberculosis compared with standard of care

This research study is investigating new and potentially faster ways to treat mild to moderate tuberculosis, a serious infection. Currently, TB treatment can take many months. Scientists are examining if giving higher doses of two established medicines, rifampicin and pyrazinamide, can shorten the overall treatment time while still being effective and safe. The study will carefully look at how these higher doses are absorbed and processed by the body, particularly on the first day of treatment and after two weeks. By comparing this new approach with the standard treatment, researchers hope to find a more efficient way to help people recover from TB. It's a Phase II study, meaning it's exploring the best way to use these drugs.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Oestergoetland

Enrolment target

Start

18 Oct 2024

Tuberculosis

What is this study about?

Tuberculosis, often called TB, is an infection that mainly affects the lungs. It can also affect other parts of the body. Currently, treating TB can be a long process, often taking several months, which can be challenging for people and sometimes leads to them not finishing their full course of medication.

This study is trying to find out if there's a better, quicker way to treat mild to moderate TB. The researchers are focusing on two medicines that are already used to treat TB: rifampicin and pyrazinamide. They want to see if using slightly higher doses of these medicines could shorten the total treatment time, making it easier for people to complete their treatment and get well sooner.

To do this, the study will carefully monitor how the body uses these higher doses. For example, they'll check how much of the medicine gets into the bloodstream and how long it stays there, particularly when people first start taking it and after a couple of weeks. This information will help researchers understand if the higher doses are working as expected and are safe. The aim is to make TB treatment more efficient without compromising safety or effectiveness.

Key takeaways

New study for mild to moderate TB treatment.
Testing higher doses of existing TB drugs, rifampicin and pyrazinamide.
Aiming for a shorter, equally safe treatment time.
Open to adults aged 18 and over, both men and women.
Participation involves close monitoring and follow-up.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. There is no upper age limit, meaning older adults can also take part if they meet other criteria.

This study is open to both men and women. The researchers are looking for people who have been diagnosed with mild to moderate tuberculosis.

Other conditions or health factors might prevent someone from joining, even if they meet the general age and sex requirements. A doctor involved in the study would thoroughly check your medical history to make sure it's safe and appropriate for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with mild to moderate tuberculosis?
Are you willing to potentially receive either the new study treatment or standard TB care?
Are you able to attend regular clinic visits for monitoring?
Are you comfortable taking study medication as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a full health check-up to make sure it's right for you. You would then be randomly assigned to either receive the new higher-dose treatment with rifampicin and pyrazinamide, or the standard treatment for TB. This means you wouldn't get to choose which group you're in.

You would take the study medication as prescribed, and the research team would closely monitor your health. This would involve regular visits to the clinic, where you might have blood tests to check how the medicine is working in your body, and other examinations to track your TB and overall health. The specific number of visits and tests would be clearly explained to you before you agree to take part. The total duration of your participation, including medication and follow-up appointments, would be similar to or shorter than the standard TB treatment course, depending on which group you are in.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach that could potentially shorten your TB treatment time, which would be a significant benefit. However, research studies carry risks; higher doses of medication could lead to different or more intense side effects than standard doses. The research team would carefully explain any known risks, and your health would be closely monitored throughout the study. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Sweden

Common questions

What is Tuberculosis (TB)?

TB is a serious infection, often affecting the lungs, caused by bacteria. It can make you feel unwell, with symptoms like a cough, fever, and weight loss.

What is a 'Phase II study'?

A Phase II study is one of the steps in testing new treatments. It focuses on finding the right dose and checking how safe and effective a new approach is for a specific condition in a group of people.

Will I definitely get the new higher-dose treatment?

No, you would be randomly assigned to either receive the new higher-dose treatment or the standard TB treatment. This helps researchers compare the two approaches fairly.

What are rifampicin and pyrazinamide?

These are two commonly used medicines that are already proven to fight the bacteria that cause tuberculosis.

How long will the treatment last if I join?

The study is testing if treatment can be shortened. The exact duration would depend on which treatment group you are in, but the aim is either a shorter or standard length of treatment.