CTRI/2021/07/034589尚未招募不适用
A Multcenter, Case-control study on Mucormycosis in COVID-19 and Non COVID-19 patients in India (MUCOVIvi-2 Study-India)
World health Organization India Office27 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年7月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 27
- 主要终点
- To describe the patient and agents (fungi) characteristics for mucormycosis among COVID-and non-COVID associated cases in India.
研究概览
简要总结
| The COVID-19 pandemic has been associated with a rise in the serious fungal infection, ‘mucormycosis’.While our earlier study identified some risk factors for COVID-19 associated mucormycosis (CAM), more data is required to identify additional causes. We, therefore, propose to conduct this retrospective multicentre study to evaluate the possible causes associated with an increase in mucormycosis cases due to Covid-19, risk factors, treatment and outcome of these cases. A retrospective case-control study will be conducted across 27 centres in India from 1st January to 31st July. All consecutive mucormycosis cases will be enrolled (both COVID-19 related and unrelated. The standard case-record form will be used for data collection followed by analysis. Any patient factors contributing to the risk of mucormycosis in COVID-19 will be identified. The issues related to treatment and predictors of the outcome can be delineated which will help in guiding patient management. |
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive confirmed and probable (probable only for pulmonary or disseminated disease) mucormycosis cases diagnosed during the study period will be enrolled (both COVID-19 related and unrelated).
- •Additionally, for each COVID-19 associated mucormycosis (CAM), we will include two age- (± 5 years) and sex-matched cases of COVID-19 cases without mucormycosis as controls.
- •A diagnosis of mucormycosis will be made in subjects with a compatible clinical and radiological presentation and the demonstration of fungi in the tissue (or sterile body fluids) by either direct microscopy (broad ribbon-like aseptate hyphae) or isolation of Mucorales.
- •Patients will be classified as ‘proven’ mucormycosis, defined by the presence of aseptate hyphae in the biopsied sample from deep tissue or isolation of Mucorales from sterile sites.
- •â€œProbable†pulmonary or disseminated mucormycosis will be defined based on the host risk factors (both classical and putative), radiological findings, and demonstration of the fungi by either culture or cytology from any site.
- •A diagnosis of COVID-19 will be made in subjects positive for SARS-CoV-2 RNA in respiratory specimens by reverse transcription-polymerase chain reaction (RT-PCR) or a positive rapid antigen test.
- •CAM will be defined as the occurrence of proven or probable mucormycosis (up to 3 months) in COVID-19 subjects.
排除标准
- •Patients with endemic mycoses (histoplasmosis, sporotrichosis, penicilliosis), yeast infections, and allergic fungal diseases like allergic bronchopulmonary aspergillosis will not be included.
结局指标
主要结局
To describe the patient and agents (fungi) characteristics for mucormycosis among COVID-and non-COVID associated cases in India.
时间窗: 6 months
•To evaluate the risk factors for infection with Mucorales in patients confirmed with COVID-19 in the studied population.
时间窗: 6 months
•To study the treatment practices and the outcomes of the patients with mucormycosis.
时间窗: 6 months
次要结局
- To describe the types of mucormycosis (site of infection) in those infected with the disease(To assess the prevalence of mucormycosis among the COVID-19 cases in the second wave of the pandemic in India.)
研究者
研究点 (27)
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