CompletedObservational

Characteristics of the early immune response in airway and blood in people with latent tuberculosis (TB) infection and active TB disease.

Tuberculosis (TB) is a bacterial infection that mainly affects the lungs. While some people become unwell with 'active' TB, others have 'latent' TB. This means the bacteria sleep in the body without causing symptoms. Right now, doctors cannot easily tell who with latent TB will go on to develop active illness. This study, run by the University of Leicester, looks at blood and lung samples to see how the immune system responds to TB. By studying these immune patterns, researchers hope to design better tests and target preventative medicines to those who need them most. Depending on your condition, taking part involves giving blood and lung samples during routine hospital visits over up to two years. Some participants may also choose to have imaging scans and a camera check of their airways. Taking part is completely voluntary.

At a glance

Status

Completed

Sponsor

University of Leicester

Enrolment target

200

Start

07 Sep 2021

Estimated completion

12 Jun 2025

Tuberculosis

What is this study about?

Tuberculosis, commonly known as TB, is an infection caused by bacteria that usually targets the lungs. It is a serious illness, but our immune systems often fight back in different ways. Some people develop active TB disease and feel very unwell with coughs, fever, or weight loss. Many others develop what is called 'latent TB'. In latent TB, the bacteria live quietly in the body without causing any symptoms at all.

About one in ten people with latent TB will eventually develop active TB disease later in life, usually within the first two years. At the moment, doctors have no reliable test to tell who will stay well and who will become sick. Because TB treatments take months and can cause tough side effects, doctors want to make sure medicines are given to the people who truly need them.

This research project, called the EVENT TB study, aims to solve this problem. Researchers are examining blood samples and fluid from the airways to map out how the immune system behaves. By comparing people with active TB, people with sleeping TB, and healthy volunteers, the team hopes to find clear immune signals that show when TB is waking up.

Ultimately, this research could lead to simple, accurate tests that spot active disease early and help doctors protect people before they become seriously ill.

Key takeaways

The study looks at how the immune system responds to active and hidden (latent) TB.
It aims to find new tests to show which people with hidden TB might become unwell.
No experimental drugs are tested; researchers collect blood and lung samples.
Open to people aged 16 and older seen by the Leicester Clinical TB Service.
Most visits are planned around your routine hospital appointments to save you time.
Taking part is voluntary, and you can withdraw at any point.

Who may be eligible?

This study is open to people aged 16 and older who are being seen by the Leicester Clinical TB Service. This includes people who are suspected of having active TB, people who have recently spent time close to someone with active TB, and healthy volunteers.

You will not be able to join if you are pregnant or breastfeeding, or if you have donated a large amount of blood recently. The study is also not suitable for people with conditions or treatments that weaken the immune system, such as high-dose steroid tablets.

Additionally, you cannot take part if you have had treatment for active TB in the past two years, treatment for latent TB in the past five years, or if you have recently taken part in another clinical trial testing a new medicine.

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.

I am aged 16 or over.
I am being seen by the Leicester Clinical TB Service (or have been in close contact with someone with TB).
I am not pregnant and not breastfeeding.
I am not taking strong medications that suppress my immune system (like oral steroids).
I have not received treatment for active TB in the last 2 years, or latent TB in the last 5 years.

Answer every question to see your result.

What does participation involve?

What taking part looks like depends on your TB diagnosis. If you have sleeping (latent) TB, you may attend up to 11 short visits over two years. Most visits take less than an hour and are arranged alongside your normal NHS hospital appointments. If needed, some visits can take place in your home. You will give blood samples and may be invited to have an optional lung check called a bronchoscopy (where a thin, flexible tube looks inside your airways) and special imaging scans.

If you have active TB disease, you will usually only need one study visit, lined up with your regular clinic appointment. If your doctor already needs to check your airways as part of your normal medical care, the team may collect research samples at the same time.

This is an observational study, which means you will not be asked to take any experimental medicines. You will continue to receive your usual NHS medical care throughout.

Potential risks and benefits

Taking part does not guarantee any direct medical benefit, but you will receive close health monitoring by a specialist team, and any signs of illness will be treated quickly. Your involvement could also help future patients receive better, more targeted TB care. The tests in this study are generally safe. If you choose to have a bronchoscopy, you might have a mild sore throat, hoarseness, or a cough with tiny specks of blood for a few days. Scans use a small dose of radiation, which carries a very low estimated risk (an increase of about 0.2% to 0.24% in lifetime cancer risk). You are completely free to leave the study at any time without your regular NHS care being affected.

Locations (1)

Glenfield Hospital
Approximate
Leicester, England

Common questions

Will I have to take any new or untested drugs?

No. This is an observational study. Researchers are only studying blood and lung samples to learn about your immune system. You will receive standard NHS care.

Do I have to agree to the lung camera test (bronchoscopy)?

No. The research bronchoscopy is entirely optional for people with latent TB. You can still take part in other parts of the study if you prefer not to have it.

Will this study take up a lot of my time?

The research team keeps visits as short as possible (usually under an hour) and links them to your routine hospital appointments so you do not have to make extra trips.

What happens if I start feeling unwell during the study?

You will be monitored regularly by the specialist TB team. If you show any signs of developing active TB, you will be assessed and treated straight away.

Can I change my mind after joining?

Yes. Taking part is completely your choice. You can withdraw at any time without giving a reason, and your normal medical care will continue as usual.

How to find out more

Jee Whang Kim

jwk12@leicester.ac.uk +44 (0)116 258 3911 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.