A study on the short and long term outcomes of patients diagnosed with a fungal disease called Mucormycosis (commonly known as Black Fungus)

Not yet recruiting

Conditions: Disseminated mucormycosis, (2) ICD-10 Condition: B462||Gastrointestinal mucormycosis, (3) ICD-10 Condition: B460||Pulmonary mucormycosis, (4) ICD-10 Condition: B461||Rhinocerebral mucormycosis,

Registration Number: CTRI/2021/09/036254

Lead Sponsor: Dr Manickam P

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 480

Inclusion Criteria

Mucormycosis patients admitted between 1st March 2021 and 31st July 2021.
Hospitalised for Mucormycosis in the study hospital.

Exclusion Criteria

Mucormycosis patients who could not be contacted despite two phone calls.
Not available for follow-up during the study period.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	1, 3, 6, and 12 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life (EQ-5D)	1, 3, 6, and 12 months
Diability	1, 3, 6, and 12 months

Trial Locations

Locations (29): (GMERS) Gujarat Medical Education & Research Society Medical College
🇮🇳
Ahmadabad, GUJARAT, India
AIIMS Bathinda
🇮🇳
Bathinda, PUNJAB, India
AIIMS Bhubaneswar
🇮🇳
Khordha, ORISSA, India
AIIMS Raipur
🇮🇳
Raipur, CHHATTISGARH, India
AIIMS Rishikesh
🇮🇳
Dehradun, UTTARANCHAL, India
Apollo Hospitals
🇮🇳
Chennai, TAMIL NADU, India
C U Shah Medical College and Hospital
🇮🇳
Surendranagar, GUJARAT, India
D.Y Patil Medical College
🇮🇳
Pune, MAHARASHTRA, India
Dr. Vasantrao Pawar Medical College, Hospital & Research Centre
🇮🇳
Nashik, MAHARASHTRA, India
Employees State Insurance Corporation
🇮🇳
Hyderabad, TELANGANA, India
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(GMERS) Gujarat Medical Education & Research Society Medical College
🇮🇳Ahmadabad, GUJARAT, India
Dr Parul Sharma
Principal investigator
7020375265
paru_1sharma@yahoo.co.in