Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-30 @ 8:09 PM
Study NCT ID:
NCT06305468
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014123', 'term': 'Toxoplasmosis'}], 'ancestors': [{'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate in intensive care.', 'timeFrame': '11 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hospital mortality rate', 'timeFrame': '11 years'}, {'measure': 'Length of stay in intensive care', 'timeFrame': '11 years'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': '11 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['toxoplasmosis'], 'conditions': ['Toxoplasmosis']}, 'descriptionModule': {'briefSummary': 'Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients.\n\nThis 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.', 'detailedDescription': '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).\n\nThis 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."\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in intensive care for toxoplasmosis (positive toxoplasmosis PCR) between 2012 (01/01/2012) and 2023 (02/01/2023)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient hospitalized in intensive care\n* At least 1 organ failure (SOFA\\> or =2)\n* PCR toxoplasmosis on CSF, blood, BAL, or bone marrow positive within 7 days before or after admission to ICU\n\nExclusion Criteria:\n\n* Post-mortem diagnosis\n* Primary outcome not available\n* Patient living informed and not opposed to the reuse of their data in this research.'}, 'identificationModule': {'nctId': 'NCT06305468', 'acronym': 'TOXIC', 'briefTitle': 'Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis - Toxoplasmosis in ICU (TOXIC)', 'orgStudyIdInfo': {'id': 'APHP240055'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clara Vigneron, MD', 'role': 'CONTACT', 'email': 'clara.vigneron@aphp.fr', 'phone': '06 33 14 56 50'}], 'facility': 'Cochin hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Clara Vigneron, MD', 'role': 'CONTACT', 'email': 'clara.vigneron@aphp.fr', 'phone': '06 33 14 56 50'}, {'name': 'Romain Sonneville, MD, PhD', 'role': 'CONTACT', 'email': 'romain.sonneville@aphp.fr', 'phone': '01 40 25 61 39'}], 'overallOfficials': [{'name': 'Clara Vigneron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}