Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06305468
Other study ID # APHP240055
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2026

Study information

Verified date March 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Clara Vigneron, MD
Phone 06 33 14 56 50
Email clara.vigneron@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients. There are different clinical forms: cerebral toxoplasmosis on the one hand, and disseminated form on the other. However, few studies have looked at the prognosis of severe toxoplasmosis hospitalized in intensive care. Historically, the diagnosis was made according to a set of clinical-biological arguments and the response to the test treatment. Polymerase chain reaction (PCR) diagnosis has significantly changed diagnostic management. One study reported 38 cases of disseminated toxoplasmosis (positive blood PCR or Bronchoalveolar lavage (BAL) or bone marrow or parasite found on biopsy of at least one organ) in HIV-infected patients who received allogeneic transplants over a 10-year period (2002 to 2012). This study did not include an analysis of these 2 subgroups, which probably have their own specificity, and no comparison of the efficacy of the different treatment regimens was performed. Another study reported 100 cases of cerebral toxoplasmosis in HIV patients hospitalized in intensive care units; only 21% of cases had a positive PCR on cerebrospinal fluid (CSF). The standard curative treatment for toxoplasmosis is pyrimethamine-sulfadiazine per os. However, in intensive care, trimethoprim-sulfamethoxazole (TMP-SMX) IV or the combination of oral pyrimethamine and IV clindamycin are sometimes used if the parenteral route is preferred. No studies have been carried out in intensive care. The latest U.S. recommendations report that "some specialists will use TMP-SMX IV (IB) or oral pyrimethamine plus IV clindamycin (IIIC) as initial treatment in severe patients requiring parenteral therapy." This descriptive study focuses on a particularly severe opportunistic infection of the immunocompromised and should allow to better specify the clinico-biological presentation of patients with disseminated or cerebral toxoplasmosis, in particular according to the type of underlying immunosuppression, in order to allow early detection of this severe complication. The identification of new categories of patients at risk, prognostic factors and the study of the impact of the use of different treatment regimens could make it possible to improve its management in intensive care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Post-mortem diagnosis - Primary outcome not available - Patient living informed and not opposed to the reuse of their data in this research.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Cochin hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hospital mortality rate 11 years
Secondary Length of stay in intensive care 11 years
Secondary Duration of mechanical ventilation 11 years
See also
  Status Clinical Trial Phase
Completed NCT03258762 - Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects Phase 1
Completed NCT01479361 - Antiretroviral Drug Interaction Study in Volunteers With HIV Phase 1
Not yet recruiting NCT05860998 - Measuring the Prevalence of Toxoplasmosis and Its Socio-economic Consequences
Not yet recruiting NCT05783778 - Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris N/A
Not yet recruiting NCT04825600 - Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity (TOXCELL) N/A
Completed NCT03993093 - Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Recruiting NCT00004317 - Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis Phase 4
Withdrawn NCT03932656 - Latent Toxoplasmosis in Females With Borderline Personality Disorder
Not yet recruiting NCT05963295 - Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies N/A
Completed NCT02011750 - Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia Phase 4