| CTRI Number |
CTRI/2016/02/006644 [Registered on: 16/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study Mucormycosis epidemiology in India |
|
Scientific Title of Study
|
Multicenter observational study on epidemiology, treatment and outcome of Mucormycosis in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul K Patel |
| Designation |
Consultant Physician, Infectious Diseases |
| Affiliation |
Fungal Infection Study Forum |
| Address |
3rd Floor, Vedanta Inst of Med Sciences, Navarangpura. Ahmedabad.
A-703, Lovely Apartment, Plot No 5, Sector-5, Dwarka, New Delhi
Ahmadabad
GUJARAT
380009
India |
| Phone |
07926440816 |
| Fax |
|
| Email |
atulpatel65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul K Patel |
| Designation |
Consultant Physician, Infectious Diseases |
| Affiliation |
Fungal Infection Study Forum |
| Address |
3rd Floor, Vedanta Inst of Med Sciences, Navarangpura. Ahmedabad.
A-703, Lovely Apartment, Plot No 5, Sector-5, Dwarka, New Delhi
Ahmadabad
GUJARAT
380009
India |
| Phone |
07926440816 |
| Fax |
|
| Email |
atulpatel65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul K Patel |
| Designation |
Consultant Physician, Infectious Diseases |
| Affiliation |
Fungal Infection Study Forum |
| Address |
3rd Floor, Vedanta Inst of Med Sciences, Navarangpura. Ahmedabad.
A-703, Lovely Apartment, Plot No 5, Sector-5, Dwarka, New Delhi
Ahmadabad
GUJARAT
380009
India |
| Phone |
07926440816 |
| Fax |
|
| Email |
atulpatel65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mylan Pharmaceuticals Private Limited |
|
|
Primary Sponsor
|
| Name |
MYLAN PHARMACEUTICALS PRIVATE LIMITED |
| Address |
10th Floor,Prestige Platina, Block 3,Kadubeesanahalli Village,Varthur Hobli, Outer Ring Road, Bangalore 560087 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Immaculata Xess |
All India Institute of Medical Sciences |
Department of Microbiology
All India Institute of Medical Sciences, New Delhi, 110029
New Delhi
DELHI |
9818268181
immaxess@gmail.com |
| Dr Raman Sardana |
Apollo Hospital |
Indraprastha Apollo Hospitals, Sarita Vihar,
Delhi - Mathura Road,
New Delhi - 110076
New Delhi
DELHI |
9811057511
ramansardana@apollohospitals.com |
| Dr Joy Sarojini Michael |
Christian Medical College |
Department of Microbiology
Christian Medical College
Vellore 632004
Tamil Nadu , India
Vellore
TAMIL NADU |
0416-2282588
joymichael@cmcvellore.ac.in |
| Dr Sangeetha Mohan |
Christian Medical College and Hospital, |
Christian Medical College and Hospital,
Brown Road
Ludhiana, Punjab
PIN: 141008
Ludhiana
PUNJAB |
01612115782
drsangmohan@gmail.com |
| Dr Ranganathan Iyer |
Global Hospital |
Department of Clinical Microbiology
Global Hospital
Near District Collectors office
Lakdi- ka- pul
Hyderabad
Pin- 500004
Hyderabad
ANDHRA PRADESH |
040-23244444
ranganathaniyer@yahoo.com |
| Dr Rajeev Soman |
Hinduja Hospital |
PD Hinduja National Hospital and Medical Research centre
Veer Savarkar Marg
Mahim
Mumbai 400016
Mumbai
MAHARASHTRA |
9892024799
rajeev.soman@yahoo.com |
| Dr Rakesh Singh |
JIPMER |
Department of Microbiology,
JIPMER, Pondicherry 605006
Pondicherry
PONDICHERRY |
9751173425
drrakesh1976@yahoo.com |
| Dr Peralam Yegneswaran Prakash |
Kasturba Medical College - Manipal |
Department of Microbiology,
Medical Mycology Laboratory,
II floor, Center for Basic Sciences Building,
Kasturba Medical College - Manipal,
Manipal University,
Madhav Nagar, Manipal,
Udupi District,
Karnataka State,
INDIA - Pincode: 576 104
Udupi
KARNATAKA |
08202922322
prakashpy123@yahoo.co.in |
| Dr P Umabala |
Nizams Institute Of Medical Sciences |
Nizams Institute Of Medical Sciences
Panjagutta,
Hyderabad
Telengana state
PIN-500082
|
9010151200
umapamidi@gmail.com |
| Dr Arunaloke Chakrabarti |
PGIMER |
PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
0172274990
arunaloke@hotmail.com |
| Dr Malini R Capoor |
Safdarjung Hospital |
VMMC and Safdarjung Hospital,
Delhi
New Delhi
DELHI |
01126165032
rajeevmalini@rediffmail.com |
| Dr Arvind Baronia |
SGPGIMS |
SGPGIIMS
Rae Bareli Road, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH |
0522-2494479
arvindbaronia@hotmail.com |
| Dr Prakash S Shastri |
Sir Gangaram Hospital |
Sir Gangaram Hospital, Rajinder Nagar, New Delhi. 110060
New Delhi
DELHI |
9810937295
prakashshastri@live.in |
| Dr Anupma Lakra |
Sri Ramachandra Medical College |
Professor, Dept of Microbiology,
Sri Ramachandra Medical College & RI,
Porur, Chennai - 600116
Chennai
TAMIL NADU |
044-24768403
anupmalakra@gmail.com |
| Dr Jayanthi Savio |
St Johns Medical College Hospital |
St.Johns Medical College Hospital,
Sarjapur Road,
Bangalore 560034
Bangalore
KARNATAKA |
08049466253
jayanthisjmc@gmail.com |
| Dr Atul K Patel |
Sterling Hospital |
Sterling Hospital, Off Gurukul Road. Memnagar. Ahmedabad
Ahmadabad
GUJARAT |
07926440816
atulpatel65@gmail.com |
| Dr Sanjay K Biswas |
Tata Memorial Hospital |
Dept of Microbiology,
6th Floor, Annexe Bldg,
Tata Memorial Hospital,
E. Borges Rd,
Parel, Mumbai-400012.
Mumbai
MAHARASHTRA |
02224177098
skbiswas67@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) of SGPGIMS |
Approved |
| CMC Ludhiana |
Approved |
| Ethics Committee on Clinical Trials, Indraprastha Apollo Hospital |
Submittted/Under Review |
| Ethics Committee Sir Gangaram Hospital |
Submittted/Under Review |
| INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Submittted/Under Review |
| Institute ethics committee, PGIMER |
Submittted/Under Review |
| Institutional Ethics Committee, Global Hospital, Hyderabad |
Submittted/Under Review |
| IRB CMC Vellore |
Approved |
| JIPMER Institute Ethics Committee (IEC)-Human Studies |
Submittted/Under Review |
| KASTURBA MEDICAL COLLEGE & KASTURBA HOSPITAL, MANIPAL INSTITUTIONAL ETHICS COMMITTEE |
Submittted/Under Review |
| NIMS Institutional Ethics committee |
Approved |
| P. D. Hinduja Hospital and Medical Research Center |
Submittted/Under Review |
| Sri Ramchandra University |
Approved |
| St Johns National Academy of Health Science Institutional EC |
Approved |
| Sterling Hospital Ethics Committee |
Approved |
| Tata Memorial Hospital IRB |
Submittted/Under Review |
| VMMC and Safdarjung Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients who diagnosed with Mucormycosis, (1) ICD-10 Condition: B46||Zygomycosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Any age group of patients with confirmed & probable diagnosis of Mucormycosis will be enrolled for this study |
|
| ExclusionCriteria |
| Details |
Any subject without a confirmed diagnosis of mucormycosis. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Overall survival at 45 and 90 days
2.Cure: defined as complete resolution of clinical, radiological and mycological evidence
3.Improved: Resolution of clinical features, radiological regression
outcome of mucormycosis in India |
45 and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grade III and IV toxicities of antifungal agents |
45 days |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "465"
Final Enrollment numbers achieved (India)="465" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2016 |
| Date of Study Completion (India) |
31/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| | Multicenter observational study on epidemiology, treatment and outcome of Mucormycosis in India | | Short Title | Description of epidemiology, treatment practice and outcome of mucomycosis in India | | Protocol Number | FISF 001.3 | | Phase | IV | | Methodology | Observational study | | Study Duration | 1 years | | Study Center(s) | Multi-center. | | Objectives | Primary: - To describe the epidemiology, diagnosis, treatment practices and outcome of mucormycosis in India Secondary: - Sites involved in mucormycosis - Underlying disease and risk factors for mucormycosis - Spectrum of agents causing mucormycosis – mode of diagnosis of mucormycosis | | Number of Subjects | At least 300 | | Diagnosis and Main Inclusion Criteria | Proven and probable cases of mucormycosis | | | No study product will be used as it is only observational study | | | not applicable | | | Not applicable | | | Descriptive and quantitative statistics | |