CTRI/2021/07/034589 [Registered on: 05/07/2021] Trial Registered Prospectively
Last Modified On:
21/10/2021
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Case Control Study
Study Design
Other
Public Title of Study
Mucormycosis(fungal infection) patients with and without COVID-19
Scientific Title of Study
A Multcenter, Case-control study on Mucormycosis in COVID-19 and Non COVID-19 patients in India (MUCOVIvi-2 Study-India)
Trial Acronym
MUCOVI-2
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Arunaloke Chakrabarti
Designation
Professor and Head of Department
Affiliation
Post Graduate Institute of Medical Education and Research
Address
Department of Medical Microbiology, PGIMER, Chandigarh
Chandigarh CHANDIGARH 160012 India
Phone
Fax
Email
arunaloke@hotmail.com
Details of Contact Person Scientific Query
Name
Dr Arunaloke Chakrabarti
Designation
Professor and Head of Department
Affiliation
Post Graduate Institute of Medical Education and Research
Address
Department of Medical Microbiology, PGIMER, Chandigarh
Chandigarh CHANDIGARH 160012 India
Phone
Fax
Email
arunaloke@hotmail.com
Details of Contact Person Public Query
Name
Dr Arunaloke Chakrabarti
Designation
Professor and Head of Department
Affiliation
Post Graduate Institute of Medical Education and Research
Address
Department of Medical Microbiology, PGIMER, Chandigarh
Chandigarh CHANDIGARH 160012 India
Phone
Fax
Email
arunaloke@hotmail.com
Source of Monetary or Material Support
World health Organization (India Office),
Office of the WHO Representative to India 537, A Wing, Nirman Bhawan Maulana Azad Road New Delhi 110 011
Primary Sponsor
Name
World health Organization India Office
Address
Office of the WHO Representative to India
537, A Wing, Nirman Bhawan
Maulana Azad Road
New Delhi 110 011, India
Type of Sponsor
Other [World health Organization (India Office)]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 27
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Immaculata Xess
All India Institute of Medical sciences, New- Delhi
Dept. of Microbiology
AIIMS, Delhi
New Delhi DELHI
9818268181
immaxess@gmail.com
Dr Vinay Hallur
All India Institute of Medical Sciences, Bhubaneswar
Department of Microbiology, Sijua, Patrapada, Bhubaneswar, Odisha 751019 Baleshwar ORISSA
9041018625
vinay118@gmail.com
Dr Nandini S
Apollo Hospital Chennai
Department of Microbiology, 21 Greams Lane, Off, Greams Road, Thousand Lights, Chennai, Tamil Nadu 600006 Chennai TAMIL NADU
9855700393
drnandinipgi@gmail.com
Dr Manoj Shevkani
Avron Hospital
Dept. of infectious Disease, Avron hospital , 4, Shantiniketan Park, Sardar Patel Colony, Ahmedabad, Gujarat 380013 Ahmadabad GUJARAT
9825431324
shevkanimanoj@gmail.com
Dr Surabhi Madan
Care Institute of Medical Sciences (CIMS) Hospital
Department of Infectious Diseases, Science City Rd, Science City, Panchamrut Bunglows II, Sola, Ahmedabad, Gujarat 380060 Ahmadabad GUJARAT
9712971863
drsurabhimadan@gmail.com
Dr Dharmesh Patel
City Clinic and Bhailal Amin General Hospital , Vadodara
Department of Pulmonology and Chest Medicine, Bhailal Amin Marg, Road, Gorwa, Vadodara, Gujarat 390003 Vadodara GUJARAT
9879519889
pateldbp@gmail.com
Dr Laxmikant Yenge
Deenanath Mangeshkar Hospital and Research Center
Department of Pulmonary Medicine and Critical Care,
Near Mhatre Bridge,Erandawne, Pune 411004 Pune MAHARASHTRA
2040151000
drlucky19@gmail.com
Dr Manish Munjal
DMC, Ludhiana
Department of ENT,Dayanand Medical College, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001 Ludhiana PUNJAB
9814328982
dr_manish_munjal@dmch.edu
Dr Varsha Gupta
Government Medical College, Chandigarh
Department of Microbiology, GMCH-32, Chandi Path, Sector 32B, Chandigarh, 160047 Chandigarh CHANDIGARH
9646121571
varshagupta_99@yahoo.com
Dr Raminder Sibia
Government Medical college, Patiala
Dept. of Medicine, Government Medical college,
Sangrur Rd, opposite Rajindra Hospital, New Lal Bagh Colony, Punjab 147001, Patiala PUNJAB
9814246633
drsibia1@yahoo.com
Dr Ravindra Mehta
Imperial Hospital And Research Centre (Apollo) Bannerghatta
Department of Pulmonology and Critical Care, 154, 11, Bannerghatta Main Rd, opp. IIM, Krishnaraju Layout, Amalodbhavi Nagar, Panduranga Nagar, Bengaluru, Karnataka 560076 Bangalore KARNATAKA
8026304050
ravihetal@gmail.com
Dr Ragini Tilak
Institute of Medical Sciences B.H.U,Varanasi
Department of Microbiology, Aurobindo Colony, Banaras Hindu University Campus, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH
9918666501
raginijain29@rediffmail.com
Dr Ashwini Tayade
Kingsway Hospital
Department of Infectious Diseases, SPANV Medisearch Lifesciences Pvt. Ltd., kingsway hospital 44, Kingsway Near Kasturchand Park, Nagpur, Maharashtra 440001 Nagpur MAHARASHTRA
8408871177
drashwini.tayade@gmail.com
Dr Tanu Singhal
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Department of Pediatrics, Rao Saheb, Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai, Maharashtra 400053 Mumbai (Suburban) MAHARASHTRA
9320211770
tanusinghal@yahoo.com
Dr Deepak Thangaraju
Kovai Medical Center and Hospital
Department of Microbiology, Avinashi Rd, Peelamedu, Indira Nagar, Civil Aerodrome Post, Tamil Nadu 641014 Coimbatore TAMIL NADU
9814453433
drdeepaktju@gmail.com
Dr Vasant Nagvekar
Lilavati Hospital
Department of Internal Medicine, A-791, Bandra Reclamation Rd, General Arunkumar Vaidya Nagar, Bandra West, Mumbai, Maharashtra 400050 Mumbai (Suburban) MAHARASHTRA
9820055178
drnagvekar@gmail.com
Dr Sanjay Pujari
Poona Hospital & Research
Deptartment of Medicine, Centre 27, Sadashiv Peth, Nr. Alka Talkies, Pune 411030, Maharashtra Pune MAHARASHTRA
9822058985
sanjaypujari@gmail.com
Dr Arunaloke Chakrabarti
Post Graduate Institute of Medical Education and Research
Department of Medical Microbiology, Research Block A, 2nd floor, PGIMER,Chandigarh Chandigarh CHANDIGARH
9914208244
arunaloke@hotmail.com
Dr Puneet Saxena
R and R Hospital, New Delhi
Department of Medicine, Army R and R Hospital, Dhaula Kuan, Delhi · Delhi Cantt, Dhaula Kuan, Delhi - 110010 New Delhi DELHI
7798982797
drsaxenap@gmail.com
Dr Arjun Srinivasan
Royal Care Hospitals
Dept. of Interventional Pulmonologists, 1/520, L & T Bye Pass Road, Coimbatore, Tamil Nadu 641062 Coimbatore TAMIL NADU
4222227000
drarjun81@gmail.com
Dr Rungmei Marak
SGPGI Lucknow
Department of Microbiology, Sanjay Gandhi Postgraduate Institute of Medical SciencesNew PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014 Lucknow UTTAR PRADESH
9839055734
rungmei@gmail.com
Dr Prakash Shastri
Sir Gangaram Hospital, Delhi
Department of allied MEdicine, institute of Critical care, Rajinder Nagar,Sir Gangaram Hospital
110060
New Delhi DELHI
9810937295
prakashshastri@live.in
Dr Sudhir Bhandari
SMS Medical College & Attached Hospitals
Department of Internal Medicine,Diabetes and Endocrinology, J.L.N. Marg, pincode: 302004 Jaipur RAJASTHAN
9829078844
principalsmsmc@rajasthan.gov.in
Dr Pratik Savaj
Smt. Rasilaben Sevantilal Shah Venus Hospital
Depart ment of infectious Diseases, Ashakatashram Campus, Venus Hospital Rd, near Lal Darwaja Flyover, Surat, Gujarat 395003 Surat GUJARAT
9429889450
pratiksavaj2@gmail.com
Dr Jayanthi Savio
St Johns Medical College & Hospital
Department of Microbiology, SJMC, Sarjapur Road, Bangalore - 560034, Karnataka Bangalore KARNATAKA
9880250127
jayanthisjmc@gmail.com
Dr Atul Patel
Sterling Hospital
department of Infectious Diseases, Near Agracent High
School, Near Gurukul,
Sterling Hospital Road,
Memnagar,
Ahmedabad,
Gujarat-380052 Ahmadabad GUJARAT
9426182696
atulpatel65@gmail.com
Dr Nagarjuna Maturu
Yashoda Hospitals, Somajiguda, Hyderabad
Department of Pulmonology, Raj Bhavan Rd, Matha Nagar, Somajiguda, Hyderabad, Telangana 500082 Hyderabad TELANGANA
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
1.00 Day(s)
Age To
99.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
Patients with endemic mycoses (histoplasmosis, sporotrichosis,
penicilliosis), yeast infections, and allergic fungal diseases like
allergic bronchopulmonary aspergillosis will not be included.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To describe the patient and agents (fungi) characteristics for mucormycosis among COVID-and non-COVID associated cases in India.
• To evaluate the risk factors for infection with Mucorales in patients confirmed with COVID-19 in the studied population.
• To study the treatment practices and the outcomes of the patients with mucormycosis.
6 months
Secondary Outcome
Outcome
TimePoints
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.
To evaluate the predictors of mortality in COVID-19 associated mucormycosis (CAM).
6 months
Target Sample Size
Total Sample Size="300" Sample Size from India="300" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
21/07/2022
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
There are no results yet.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
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).
What additional supporting information will be shared? Response - Study Protocol
Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available? Response - For individual participant data meta-analysis.
By what mechanism will data be made available? Response - Proposals should be directed to [arunaloke@hotmail.com].
For how long will this data be available start date provided 01-08-2021 and end date provided 31-12-2021? Response - Beginning 3 months and ending 5 years following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
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.