NCT06305468

Brief Summary

Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients. This study should make it possible to evaluate the impact of different anti-infective treatment regimens and to highlight clinical-biological and prognostic differences depending on the type of underlying immunosuppression.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

March 5, 2024

Last Update Submit

January 24, 2025

Conditions

Toxoplasmosis

Keywords

toxoplasmosis

Outcome Measures

Primary Outcomes (1)

  • Mortality rate in intensive care.

    The aim is to determine the impact of the anti-infective treatment regimen used on the prognosis of patients with severe toxoplasmosis in intensive care.

    11 years

Secondary Outcomes (3)

  • Hospital mortality rate

    11 years

  • Length of stay in intensive care

    11 years

  • Duration of mechanical ventilation

    11 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in intensive care for toxoplasmosis (positive toxoplasmosis PCR) between 2012 (01/01/2012) and 2023 (02/01/2023)

You may qualify if:

  • Adult patient hospitalized in intensive care
  • At least 1 organ failure (SOFA\> or =2)
  • PCR toxoplasmosis on CSF, blood, BAL, or bone marrow positive within 7 days before or after admission to ICU

You may not qualify if:

  • Post-mortem diagnosis
  • Primary outcome not available
  • Patient living informed and not opposed to the reuse of their data in this research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin hospital

Paris, France, 75014, France

RECRUITING

MeSH Terms

Conditions

Toxoplasmosis

Condition Hierarchy (Ancestors)

CoccidiosisProtozoan InfectionsParasitic DiseasesInfections

Study Officials

  • Clara Vigneron, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Vigneron, MD

CONTACT

06 33 14 56 50clara.vigneron@aphp.fr

Romain Sonneville, MD, PhD

CONTACT

01 40 25 61 39romain.sonneville@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

August 1, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)