Mucormycosis(fungal infection) patients with and without COVID-19
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/07/034589
- Lead Sponsor
- World health Organization India Office
- Brief Summary
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|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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 300
- 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.
- “Probable†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. 6 months •To evaluate the risk factors for infection with Mucorales in patients confirmed with COVID-19 in the studied population. 6 months •To study the treatment practices and the outcomes of the patients with mucormycosis. 6 months
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (27)
All India Institute of Medical sciences, New- Delhi
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences, Bhubaneswar
🇮🇳Baleshwar, ORISSA, India
Apollo Hospital Chennai
🇮🇳Chennai, TAMIL NADU, India
Avron Hospital
🇮🇳Ahmadabad, GUJARAT, India
Care Institute of Medical Sciences (CIMS) Hospital
🇮🇳Ahmadabad, GUJARAT, India
City Clinic and Bhailal Amin General Hospital , Vadodara
🇮🇳Vadodara, GUJARAT, India
Deenanath Mangeshkar Hospital and Research Center
🇮🇳Pune, MAHARASHTRA, India
DMC, Ludhiana
🇮🇳Ludhiana, PUNJAB, India
Government Medical College, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Government Medical college, Patiala
🇮🇳Patiala, PUNJAB, India
Scroll for more (17 remaining)All India Institute of Medical sciences, New- Delhi🇮🇳Delhi, DELHI, IndiaDr Immaculata XessPrincipal investigator9818268181immaxess@gmail.com