RecruitingOBSERVATIONAL

Sputum-free Diagnostis of TB

This study is looking for better ways to test for tuberculosis (TB). TB is an infection that usually affects the lungs but can affect other parts of the body too. Currently, diagnosing TB often involves testing spit (sputum), which can be difficult for some people to produce. Researchers hope to find new, simpler ways to diagnose TB using other body samples like blood, urine, or stool. Their goal is to identify special 'biomarkers' in these samples that act like a signal for TB. If successful, this could lead to easier and quicker diagnosis. Taking part means you'd provide samples once, and it wouldn't change your usual medical care.

At a glance

Status

Recruiting

Sponsor

Research Center Borstel

Enrolment target

100

Start

06 Jun 2025

Estimated completion

01 Dec 2026

Tuberculosis

What is this study about?

This study is all about finding new and easier ways to diagnose tuberculosis (TB). TB is a serious infection, and it's really important to find out if someone has it so they can get the right treatment. Currently, doctors often test spit (what's called sputum) to diagnose TB. However, some people, especially children or those who are very unwell, find it hard to produce enough spit for testing.

That's where this study comes in. Researchers are looking for special clues, called 'biomarkers', in other body fluids like blood, urine, or even stool (poo). These biomarkers could be signs that TB is present. By studying these samples from people who might have TB, the researchers hope to develop new tests that are easier and less invasive than current methods. Think of it like a detective looking for different types of fingerprints to solve a case.

The main goal is to create reliable tests that don't depend on spit samples, making it simpler to diagnose TB for everyone. This could speed up diagnosis, meaning people get treated faster and potentially stop the spread of the infection. The study is particularly interested in whether a single biomarker, or a combination of them, could provide an accurate diagnosis.

Key takeaways

This study aims to find new, easier ways to test for Tuberculosis (TB).
It uses samples like blood, urine, and stool to look for clues (biomarkers).
Your routine medical care will not be affected if you take part.
Participation involves providing samples just once.
The study focuses on adult patients with suspected TB or other lung infections.
Helping this study could lead to better TB diagnosis for many people.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be able to take part if your doctors suspect you have TB, either in your lungs or other parts of your body, or if you've recently been diagnosed and have only had TB treatment for less than a week. We also need people who have a different lung infection (not TB) to help us compare.

To join, you must be able to understand what the study involves and agree to take part. It's important that you want to participate.

If you are under 18, pregnant, or unable to give your agreement to join, then unfortunately you won't be able to be part of this particular 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 18 years old or older?
Do you have suspected TB, or confirmed TB and have been on treatment for less than 7 days?
Or do you have a different lung infection (not TB)?
Are you able to understand the study and willing to take part?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your participation would be quite straightforward. You would need to provide a set of different body samples just once. These include blood, urine, stool (poo), and a sputum (spit) sample if you are able to produce one. Your regular medical tests and care wouldn't change or be affected by your involvement in the study. You won't need to have any extra examinations or procedures beyond providing these samples. This is a one-off sample collection and there are no further follow-up visits or medication involved specifically for the study.

Potential risks and benefits

The main benefit of taking part is helping researchers find better ways to diagnose TB, which could help many people in the future. There are very few risks expected, as the study only involves providing samples, similar to what you might do during a routine doctor's visit. You won't have any extra invasive procedures. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is TB?

TB (Tuberculosis) is a serious infection, usually affecting the lungs, but it can also affect other parts of the body.

Why is this study important?

This study is important because it aims to find easier ways to diagnose TB, especially for people who can't produce spit for traditional tests.

What are 'biomarkers'?

Biomarkers are like clues in your body (like in blood or urine) that can signal if you have a certain condition, like TB.

Will my usual treatment be affected?

No, your usual medical care and treatment will continue exactly as normal and won't be changed by taking part in this study.

Do I have to give a spit sample?

You will be asked for a spit sample, but only if you are able to produce one. Other samples like blood, urine, and stool are also collected.

How to find out more

Thomas Theo Brehm, Dr. med.

tbrehm@fz-borstel.de +49 4537 188 2905 Official trial record

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