1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [manickam@nie.gov.in].
   


6. For how long will this data be available start date provided 01-10-2021 and end date provided 31-10-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Mucormycosis is an angio-invasive fungal infection that is characterized by tissue infarction and necrosis. Mucormycosis is prevalent worldwide, but the exact global burden of the disease is not clear. It is the third most common invasive fungal infection associated significantly with high morbidity and mortality.¹ In the context of the ongoing Coronavirus disease 2019 (COVID-19) pandemic, increasing number of cases of Mucormycosis is reported from several Indian states recently.⁴

Although studies have reported on the clinical picture of Mucormycosis, the prognosis and the survival of these patients have never been reported through cohort studies. This multi-centric study will capture the prognosis of Mucormycosis in different settings across the country. The ambispective cohort study design proposed will ensure the capture of complete information from admission until 1 year post admission. Such information may help designing clinical and public health strategies to reduce complications and improve survival. Therefore, we propose to characterise the natural history of Mucormycosis since diagnosis and determine the factors associated with survival through an ambispective cohort study.

Objectives

The primary objective of the study is to estimate the incidence of adverse outcomes among paediatric and adult patients with Mucormycosis admitted in selected tertiary care centres in India.

Methods

We propose to conduct an ambispective cohort study with a one-year follow-up of mucormycosis patients from the time of admission for management of the condition. The study will be conducted among Mucormycosis patients being managed at selected government/private tertiary care hospitals and medical colleges that provide multidisciplinary treatment for Mucormycosis. The study is planned to commence in the first week of July 2021. The tentative period for data collection is 14 months and the study is expected to be completed by September 2022. The study population would comprise a cohort of individuals who are diagnosed with and treated for Mucormycosis in the study hospitals. The sample size is calculated to be 384. To account for a 20% non-response or loss to follow-up, the sample size is increased to 480 eligible Mucormycosis patients.

An online data capture module will be developed using REDCap (Research Electronic Data Capture), a secure web application for building and managing online surveys and databases.¹¹ Data will be analysed using STATA 17 software (Stata Corp, College Station, TX, USA). The findings of this study will be useful for characterising the natural history of Mucormycosis in India. In addition, the results will enable us to identify factors that are associated with mortality among patients with mucormycosis. The findings may help clinicians to devise optimal treatment strategies that will minimize adverse outcomes following mucormycosis.