Mucormycosis(fungal infection) patients with and without COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/07/034589
- Lead Sponsor
- World health Organization India Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Patients with endemic mycoses (histoplasmosis, sporotrichosis,
penicilliosis), yeast infections, and allergic fungal diseases like
allergic bronchopulmonary aspergillosis will not be included.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the patient and agents (fungi) characteristics for mucormycosis among COVID-and non-COVID associated cases in India. <br/ ><br>â?¢To evaluate the risk factors for infection with Mucorales in patients confirmed with COVID-19 in the studied population. <br/ ><br>â?¢To study the treatment practices and the outcomes of the patients with mucormycosis. <br/ ><br>Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method To describe the types of mucormycosis (site of infection) in those infected with the disease <br/ ><br>To assess the prevalence of mucormycosis among the COVID-19 cases in the second wave of the pandemic in India. <br/ ><br>To evaluate the predictors of mortality in COVID-19 associated mucormycosis (CAM). <br/ ><br>Timepoint: 6 months