Not yet recruitingOBSERVATIONAL

Isolated Positive Toxoplasma Gondii PCR in Blood

Toxoplasmosis is a condition caused by a parasite, and it can be very serious for people with weak immune systems. We often find early signs of this parasite in their blood using a special test called PCR. Sometimes, this positive test means someone will become very ill, while other times it just shows the parasite is there without causing major problems. Doctors sometimes call these two situations 'toxoplasmosis disease' (when someone is actually sick) and 'toxoplasmosis infection' (when the parasite is present but not causing illness). This study is looking back at records of patients who tested positive in their blood to see if we can find any clues from their medical tests or scans that tell us early on whether they will develop the actual disease or just have the infection without getting sick. This will help doctors decide on the best treatment more quickly.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

100

Start

01 Sep 2025

Estimated completion

01 Mar 2026

Toxoplasmosis

What is this study about?

Imagine you have a weakened immune system, perhaps because of another medical condition or treatment. There's a common parasite called Toxoplasma gondii, and while it might not bother most healthy people, it can cause very serious problems for someone with a vulnerable immune system. To catch it early, doctors often do regular blood tests using a method called PCR to look for tiny bits of the parasite's DNA.

Now, here's the tricky part: sometimes, this PCR test shows positive, meaning the parasite's DNA is in the blood, but the person isn't showing any symptoms and isn't actually sick. Other times, a positive test means they are about to become very ill. Doctors need to know the difference quickly so they can give the right treatment.

This study is looking back at the medical records of patients who had a positive Toxoplasma PCR blood test. We are trying to find patterns in their other test results, scans, or symptoms that can help doctors tell, right from that first positive test, if someone is likely to develop the serious illness (toxoplasmosis disease) or if it's just the parasite being detected without causing much harm (toxoplasmosis infection). By understanding this better, doctors can make more informed decisions about when and how to treat patients, potentially preventing serious health issues.

Key takeaways

The study aims to improve early diagnosis of serious toxoplasmosis.
It focuses on patients with weakened immune systems and early positive blood tests.
Researchers are looking for clues in existing medical records.
The goal is to help doctors tell the difference between mild infection and serious illness sooner.
This is a 'retrospective' study, meaning no new patient involvement is needed.
Understanding this could lead to better and faster treatment decisions for future patients.

Who may be eligible?

This study is looking at information from medical records of people who have already had a positive blood test for Toxoplasma gondii. We are interested in patients who had this positive test during the study period and who hadn't shown any symptoms of toxoplasmosis since their last negative test. Also, they shouldn't have had a positive test for Toxoplasma gondii in any body fluid for the six weeks leading up to this new positive blood test.

However, some people will not be included. For example, if there was a mistake with the blood sample that made the test look positive when it wasn't, or if we don't know if the person's immune system had previously been exposed to toxoplasmosis. People who already have a clear diagnosis of toxoplasmosis due to an acute infection, or specific types like inherited toxoplasmosis (congenital), eye toxoplasmosis (ocular), or toxoplasmosis in people with HIV/AIDS, will not be part of this particular study.

Finally, if a patient, or their family on their behalf, has said they do not want their medical information used for research, they will not be included.

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 had a recent positive blood test for Toxoplasma gondii?
Have you *not* had any clear symptoms of toxoplasmosis since your last negative test?
Did you *not* have any positive Toxoplasma tests in the 6 weeks before this recent positive blood test?
Is your medical record clear that no errors were made during your blood testing?
Have you *not* been diagnosed with specific types like congenital or ocular toxoplasmosis, or toxoplasmosis with HIV/AIDS?

Answer every question to see your result.

What does participation involve?

This study is a ‘retrospective’ study, which means we are looking back at information from medical records that have already been collected as part of your routine care. You will not have any extra appointments, tests, or treatments as part of this study. Your participation simply means that your past medical information, already recorded, will be reviewed by researchers to help answer the study's questions. There is no medication involved directly with the study itself, nor any follow-up appointments related to the study.

Potential risks and benefits

Since this study only involves reviewing existing medical records, there are no physical risks like those from new medications or procedures. The main potential benefit is that by understanding more about early toxoplasmosis detection, future patients may receive more timely and appropriate care, potentially preventing serious illness. Your privacy will be protected – all personal information will be kept confidential, and your identity won't be revealed. Participation in studies like this is voluntary, and you always have the right to withdraw your permission for your past data to be used in the study, even after it has started.

Locations (1)

CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France

Common questions

What is Toxoplasmosis?

It's a condition caused by a common parasite called Toxoplasma gondii, which can be serious for people with weakened immune systems.

What is a PCR test?

It's a special blood test that can find tiny bits of the parasite's genetic material (DNA) extremely early.

What's the difference between 'toxoplasmosis disease' and 'toxoplasmosis infection'?

'Disease' means you're actually sick with symptoms, while 'infection' means the parasite is present but isn't causing obvious illness.

Will I have to do anything if I participate?

No, this study only reviews existing medical records. You won't have any extra appointments, tests, or treatments.

How will my privacy be protected?

Your personal information will be kept confidential, and your identity will not be shared in the study results.

How to find out more

Lise LACLAUTRE

promo_interne_drci@chu-clermontferrand.fr 334.73.754.963 Official trial record

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