CTRI/2021/07/034589Not yet recruiting未知
A Multcenter, Case-control study on Mucormycosis in COVID-19 and Non COVID-19 patients in India (MUCOVIvi-2 Study-India) - MUCOVI-2
World health Organization India Office0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •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 â??provenâ?? mucormycosis, defined by the presence of aseptate hyphae in the biopsied sample from deep tissue or isolation of Mucorales from sterile sites. â??Probableâ?? 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.
Exclusion Criteria
- •Patients with endemic mycoses (histoplasmosis, sporotrichosis,
- •penicilliosis), yeast infections, and allergic fungal diseases like
- •allergic bronchopulmonary aspergillosis will not be included.
Investigators
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