Evaluation of a Novel Microbiological Diagnostic Test for Latent Mycobacterium Tuberculosis Infection
Tuberculosis (TB) is a bug that can cause a serious lung infection. Many people have a 'dormant' form, meaning the bug is in their body but not making them sick. While most people with dormant TB never get sick, some do. Current tests can't tell the difference or show if treatment has worked. Scientists in Germany found a new blood test that can detect tiny numbers of TB bugs in people with dormant TB. This study will check if this new test works in a larger group of 100 people. If it does, it could lead to much better tests for dormant TB, helping doctors to provide the right treatment to the right people.
At a glance
What is this study about?
Tuberculosis (TB) is an infection caused by tiny germs. Most of the time, these germs affect the lungs. People usually catch TB if they breathe in germs coughed into the air by someone with active TB. For many, the germs stay 'dormant' in the body, meaning they don't cause any sickness. However, about 1 in 10 people with dormant TB will eventually become ill with active TB, which can cause symptoms like a persistent cough and losing weight.
There's good news: dormant TB can be treated with antibiotics over three months, which helps prevent it from turning into active TB. The problem is, current tests for dormant TB don't look for the germs themselves; they simply check for your body's reaction to the germs. This means these tests don't change after you've been treated, so doctors can't tell if the treatment has actually worked. Also, these tests can't tell who among those with dormant TB will get sick and who won't, leading to many more people taking antibiotics than truly need them.
Recently, some scientists in Germany had an exciting breakthrough. They developed a new, very sensitive blood test that seemed to find tiny numbers of TB germs directly in the blood of a few people with dormant TB. This was a big deal because finding the actual germs in dormant TB has been very difficult. This research study wants to check if these exciting findings are true by testing this new blood test in a larger group of about 100 people, including those with and without dormant TB. If this new test proves accurate, it could completely change how we diagnose and treat dormant TB in the future.
Key takeaways
- Exploring a new blood test for dormant TB.
- Aims to detect actual TB germs, not just the body's reaction.
- Could help doctors know if dormant TB treatment is working.
- May help identify who truly needs dormant TB treatment.
- Involves blood samples over time.
- Contributes to important future TB diagnostics.
Who may be eligible?
To take part in this study, you need to be at least 16 years old. We are looking for two main groups of people: those who are currently being checked for dormant TB, and those who have recently been diagnosed with active TB and are about to start treatment.
There are some reasons why you might not be able to join. For example, if you have HIV, have already received treatment for TB in the past, or if doctors suspect you have active TB and you haven't started treatment yet, you wouldn't be able to participate. We also can't include you if you've already started taking medicine for dormant TB, or if your blood haemoglobin (a measure of your red blood cells) is too low.
Crucially, everyone who takes part must be willing to give written permission to be in the study.
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 aged 16 years or over?
- Are you currently being screened for dormant TB OR have you recently been diagnosed with active TB and are about to start treatment?
- Have you not had treatment for TB before?
- Do you not have HIV?
- Are you able to agree to take part by signing a consent form?
What does participation involve?
If you decide to join this study, your participation will involve providing some blood samples. For those being screened for dormant TB, you will have blood taken at the start of the study. If you go on to receive treatment for dormant TB, you will be invited to give further blood samples during and after your treatment. For those with active TB, blood samples will also be taken at the start and at various points during your treatment. The study team will explain the exact schedule of visits and blood tests based on your situation. The total duration of your involvement will depend on whether you receive treatment and how long that treatment lasts, but it will involve several visits over time.
Potential risks and benefits
Locations (1)
- Blizard Institute, Queen Mary University LondonVerified postcodeLondon, United Kingdom
Common questions
What is 'dormant TB'?
Dormant TB means you have the TB germs in your body, but they are 'asleep' and not making you sick. You can't spread it to others when it's dormant.
Why can't current tests tell if dormant TB treatment works?
Current tests check your body's immune reaction, not the germs themselves. This reaction often stays positive even after the germs are treated, so the test result doesn't change.
What is new about this blood test?
This new test aims to find the actual TB germs in your blood, rather than just your body's response, which could be a big step forward.
Will I get free treatment if I join?
This study is testing a new diagnostic method, not providing treatment. Any treatment you receive will be part of your standard medical care, as decided by your doctor.
How many times will I have to give blood?
The number of times you'll give blood will depend on whether you are being treated for dormant or active TB. The study team will explain this fully.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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