Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis - Toxoplasmosis in ICU (TOXIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mortality rate in intensive care.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Post-mortem diagnosis
- •Primary outcome not available
- •Patient living informed and not opposed to the reuse of their data in this research.
结局指标
主要结局
Mortality rate in intensive care.
时间窗: 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.
次要结局
- Duration of mechanical ventilation(11 years)
- Length of stay in intensive care(11 years)
- Hospital mortality rate(11 years)
