Viewing Study NCT07054918


Ignite Creation Date: 2025-12-25 @ 4:52 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
Study NCT ID: NCT07054918
Status: NOT_YET_RECRUITING
Last Update Posted: 2025-07-11
First Post: 2025-06-27
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Isolated Positive Toxoplasma Gondii PCR in Blood
Sponsor: University Hospital, Clermont-Ferrand
Organization:

Study Overview

Official Title: Isolated Positive Toxoplasma Gondii PCR in Blood
Status: NOT_YET_RECRUITING
Status Verified Date: 2025-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TIPS
Brief Summary: Toxoplasmosis in immunocompromised patients is a serious, life-threatening condition that requires rapid, appropriate treatment. Diagnosis is based on PCR, notably on blood samples. Systematic blood screening is carried out for patients most at risk, to detect the disease at an early stage. Detection of parasite DNA in blood in asymptomatic patients is possible, in the absence of Toxoplasma multiplication. It has previously been proposed a distinction of two entities: toxoplasmosis disease (clinical, biological and imaging evidence of toxoplasmosis) and toxoplasmosis infection (positive PCR in the blood in the absence of clinical or radiological evidence, without progression to toxoplasmosis). Since the clinical signs of toxoplasmosis are often aspecific, a positive PCR may be the first warning result, making it difficult to determine whether the patient will progress to toxoplasmosis disease or toxoplasmosis infection.

In collaboration with the French National Reference Center for toxoplasmosis, we are proposing a retrospective multicenter study to identify possible clinical, biological or imaging criteria pointing to toxoplasmosis disease or toxoplasmosis infection as soon as the first T. gondii PCR result is positive in the blood.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: