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NCT Number: NCT06305468

Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality rate in intensive care.

    Time frame: 11 years

    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.

Secondary outcomes

  1. Hospital mortality rate

    Time frame: 11 years

  2. Length of stay in intensive care

    Time frame: 11 years

  3. Duration of mechanical ventilation

    Time frame: 11 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Vigneron, MD

CONTACT

[email protected]

06 33 14 56 50

Romain Sonneville, MD, PhD

CONTACT

[email protected]

01 40 25 61 39

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis - Toxoplasmosis in ICU (TOXIC)

Acronym: TOXIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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