RecruitingNAINTERVENTIONAL

Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis

This study aims to understand how active schistosomiasis (a parasitic infection) is in people who have been diagnosed with the long-term form of the illness. These are often people who have travelled or moved to the UK from areas where the infection is common. We're using a variety of tests, including new ones, to get a clearer picture of the infection's activity. This can help improve how we diagnose and treat schistosomiasis. We will collect blood, urine, and stool samples and test them with different methods. Some samples will also be sent to a specialist lab in the Netherlands for a specific test (called UCP-LF CAA) to help us find out more about the infection's activity.

At a glance

Status

Recruiting

Phase

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Enrolment target

278

Start

28 Jun 2024

Estimated completion

01 Jan 2027

Schistosomiasis

What is this study about?

This study is about a parasitic infection called schistosomiasis. It's often picked up in certain parts of the world, and sometimes people who have travelled or moved to the UK might have had it for a long time without knowing it, or without it causing significant problems immediately. Doctors call this 'chronic schistosomiasis'. We want to find out how active the infection is in these people, because even if someone has been diagnosed, the infection might not always be causing active problems, or it might be very active and need treatment. Understanding this helps doctors decide on the best care.

To do this, we're using a range of tests. Some are standard tests that doctors already use, like looking at blood, urine, and stool samples under a microscope or doing other lab tests. We're also using some newer, sensitive tests that can detect tiny parts of the parasite. This combination of tests gives us a much more detailed picture of how active the infection currently is in each person. The results will help us improve how we diagnose and manage schistosomiasis for people in the future.

One special part of the study involves sending a small extra blood sample to a laboratory in the Netherlands. There, a particular test called UCP-LF CAA will be done. This test is designed to measure how busy the parasites are in your body which can give us a very good idea of whether the infection is currently active. The overall goal is to make sure people with schistosomiasis get the most accurate diagnosis and the most effective treatment for their situation.

Key takeaways

Study aims to check how 'active' long-term schistosomiasis infections are.
Uses a mix of standard and new tests on blood, urine, and stool samples.
Helps improve future diagnosis and treatment for schistosomiasis.
Participation involves routine checks and sample collection, no new treatment.
You can withdraw from the study at any time.
A small blood sample may be stored for future research, but this is optional.

Who may be eligible?

To join this study, you need to have been diagnosed with long-term (chronic) schistosomiasis by your local doctor. This means the infection likely started more than three months ago. If you're under 18, you'll need permission from a parent or guardian, and you'll also need to agree to take part yourself.

There are a few reasons why someone might not be able to join. For example, children under 5 years old can't take part. Also, if you've recently taken a specific medication called praziquantel (which treats schistosomiasis) after your last possible exposure to the parasite, you wouldn't be able to join this particular study. If your infection is very new (less than 3 months old), you also wouldn't be suitable for this study looking at chronic schistosomiasis.

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.

Have you been diagnosed with 'chronic' (long-term) schistosomiasis by your doctor?
Is it likely you've had the infection for more than 3 months?
Are you 5 years old or older?
Have you NOT taken praziquantel (a specific treatment) after your last possible exposure to the parasite?
Are you willing to provide blood, urine, and stool samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have a special visit where doctors will do a full check-up. This will include taking blood samples, urine samples, and stool samples. These samples will be tested using various methods, including looking at them under a microscope and using more advanced lab tests. Some of your blood samples will also be sent to a specialist lab in the Netherlands for a specific test. You might also have an ultrasound scan if your doctor thinks it's needed, but this is up to their decision. You will be asked to sign a consent form to allow your involvement in the study. There's also an optional additional consent form to allow a small part of your blood sample to be stored for 15 years for future research, but you don't have to agree to this to be part of the main study. There are no extra visits directly arranged for this study beyond your initial assessment; the information will be collected during your existing evaluation. There is no medication given as part of this study.

Potential risks and benefits

Taking part in this study won't directly improve your schistosomiasis right now, as it's purely for investigation and doesn't involve new treatments. However, the information gathered could help doctors better understand and treat schistosomiasis for many people in the future. The risks are very low; they include the small discomfort of blood tests and providing urine and stool samples. You can stop taking part in the study at any time without giving a reason, and this will not affect your medical care.

Locations (8)

Institute of Tropical Medicine (ITM)
Verified postcode
Antwerp, Belgium· Recruiting
Universitätsklinikum Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Not yet recruiting
IRCCS Policlinico Sant'Orsola
Verified postcode
Bologna, Italy· Recruiting
IRCCS Sacro Cuore Don Calabria
Verified postcode
Negrar, Italy· Recruiting
AOU Careggi
Verified postcode
Florence, Italy· Not yet recruiting
Medical Microbiology & Infectious Diseases, Erasmus MC
Verified postcode
Rotterdam, Netherlands· Not yet recruiting
Tropical Medicine Unit of Hospital de Poniente
Verified postcode
Almería, Spain· Recruiting
Vall d'Hebron University Hospital
Verified postcode
Barcelona, Spain· Recruiting

Common questions

What is schistosomiasis?

Schistosomiasis is an infection caused by tiny worms (parasites) that live in certain types of freshwater snails. People can get infected by swimming or bathing in contaminated water.

What does 'chronic schistosomiasis' mean?

Chronic means long-term. So, chronic schistosomiasis means you've had the infection for a while, usually more than three months, rather than it being a very new infection.

Why do you need so many different tests?

Using many tests helps us get the most accurate and complete picture of how active the infection is. Some tests are very good at showing if the parasite is currently active, while others confirm the infection is there.

Will I get any treatment as part of this study?

No, this study is about understanding the infection better, not about giving new treatments. Your standard medical care for schistosomiasis will continue as normal.

Is my personal information kept private?

Yes, all your personal information and test results will be kept strictly confidential and anonymous, meaning your name won't be linked to the results when they are used for research.

How to find out more

Elvia Malo

ricerca.clinica@sacrocuore.it +390456013111 Official trial record

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