PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Thu, 10 Jan :59:45 GMT) CTRI Number Last Modified On 12/02/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/02/ [Registered on: 16/02/2016] - Trial Registered Retrospectively Observational Cohort Study Other To study Mucormycosis epidemiology in Multicenter observational study on epidemiology, treatment and outcome of Mucormycosis in Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Designation Affiliation Details of Principal Investigator Dr Atul K Patel Phone Fax Designation Affiliation Consultant Physician, Infectious Diseases Fungal Infection Study Forum 3rd Floor, Vedanta Inst of Med Sciences, Navarangpura. Ahmedabad. A-703, Lovely Apartment, Plot 5, Sector-5, Dwarka, Details Contact Person (Scientific Query) Dr Atul K Patel Phone Fax Designation Affiliation Consultant Physician, Infectious Diseases Fungal Infection Study Forum 3rd Floor, Vedanta Inst of Med Sciences, Navarangpura. Ahmedabad. A-703, Lovely Apartment, Plot 5, Sector-5, Dwarka, Details Contact Person (Public Query) Dr Atul K Patel Consultant Physician, Infectious Diseases Fungal Infection Study Forum 3rd Floor, Vedanta Inst of Med Sciences, Navarangpura. Ahmedabad. A-703, Lovely Apartment, Plot 5, Sector-5, Dwarka, page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Mylan Pharmaceuticals Private Limited Type of Sponsor List of Countries of Principal Investigator Dr Immaculata Xess Source of Monetary or Material Support Primary Sponsor Details MYLAN PHARMACEUTICALS PRIVATE LIMITED 10th Floor,Prestige Platina, Block 3,Kadubeesanahalli Village,Varthur Hobli, Outer Ring Road, Bangalore Pharmaceutical industry-n of Site Site Phone/Fax/ All Institute of Medical Sciences Department of Microbiology All Institute of Medical Sciences,, Dr Raman Sardana Apollo Hospital Indraprastha Apollo Hospitals, Sarita Vihar, Delhi - Mathura Road, Dr Joy Sarojini Michael Dr Sangeetha Mohan Christian Medical College Christian Medical College and Hospital, Department of Microbiology Christian Medical College Vellore Tamil Nadu, Vellore TAMIL NADU Christian Medical College and Hospital, Brown Road Ludhiana, Punjab PIN: Ludhiana PUNJAB Dr Ranganathan Iyer Global Hospital Department of Clinical Microbiology Global Hospital Near District Collectors office Lakdika- pul Hyderabad Pin Hyderabad ANDHRA PRADESH Dr Rajeev Soman Hinduja Hospital PD Hinduja National Hospital and Medical Research centre Veer immaxess@gmail.com ramansardana@apolloh ospitals.com joymichael@cmcvellore.ac.in drsangmohan@gmail.c om ranganathaniyer@yaho o.com rajeev.soman@yahoo.c page 2 / 7

3 Savarkar Marg Mahim Mumbai Mumbai MAHARASHTRA Dr Rakesh Singh JIPMER Department of Microbiology, JIPMER, Pondicherry Pondicherry PONDICHERRY Dr Peralam Yegneswaran Prakash Dr P Umabala Dr Arunaloke Chakrabarti Kasturba Medical College - Manipal Nizams Institute Of Medical Sciences PGIMER 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: Udupi KARNATAKA Nizams Institute Of Medical Sciences Panjagutta, Hyderabad Telengana state PIN t Applicable N/A PGIMER, Chandigarh Chandigarh CHANDIGARH Dr Malini R Capoor Safdarjung Hospital VMMC and Safdarjung Hospital, Delhi Dr Arvind Baronia SGPGIMS SGPGIIMS Rae Bareli Road, Lucknow, Uttar Pradesh Lucknow UTTAR PRADESH Dr Prakash S Shastri Sir Gangaram Hospital Sir Gangaram Hospital, Rajinder Nagar, New Delhi Dr Anupma Lakra Dr Jayanthi Savio Sri Ramachandra Medical College St Johns Medical College Hospital Professor, Dept of Microbiology, Sri Ramachandra Medical College & RI, Porur, Chennai Chennai TAMIL NADU St.Johns Medical College Hospital, Sarjapur Road, Bangalore om drrakesh1976@yahoo.c om prakashpy123@yahoo. co.in umapamidi@gmail.com arunaloke@hotmail.co m rajeevmalini@rediffmail. com arvindbaronia@hotmail. com prakashshastri@live.in anupmalakra@gmail.co m jayanthisjmc@gmail.co m page 3 / 7

4 Details of Ethics Bangalore KARNATAKA Dr Atul K Patel Sterling Hospital Sterling Hospital, Off Gurukul Road. Memnagar. Ahmedabad Dr Sanjay K Biswas Tata Memorial Hospital Dept of Microbiology, 6th Floor, Annexe Bldg, Tata Memorial Hospital, E. Borges Rd, Parel, Mumbai Mumbai MAHARASHTRA skbiswas67@rediffmail. com of Approval Status Date of Approval Is Independent Ethics? Institutional Ethics (IEC) of SGPGIMS Approved 26/11/2015 CMC Ludhiana Approved 31/08/2015 Ethics on Clinical Trials, Indraprastha Apollo Hospital Ethics Sir Gangaram Hospital INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES Institute ethics committee, PGIMER Institutional Ethics, Global Hospital, Hyderabad IRB CMC Vellore Approved 05/11/2015 JIPMER Institute Ethics (IEC)-Human Studies KASTURBA MEDICAL COLLEGE & KASTURBA HOSPITAL, MANIPAL INSTITUTIONAL ETHICS COMMITTEE NIMS Institutional Ethics committee P. D. Hinduja Hospital and Medical Research Center Sri Ramchandra University Approved 12/09/2015 Approved 26/08/2015 St Johns National Approved 03/10/2015 Academy of Health Science Institutional EC page 4 / 7

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Sterling Hospital Ethics Tata Memorial Hospital IRB VMMC and Safdarjung Hospital Ethics Status t Applicable Health Type Patients Approved 06/08/2015 Approved 15/09/2015 Date Condition Patients who diagnosed with Mucormycosis Type Details Age From Age To Gender Details Details 1.00 Day(s) Year(s) Both Inclusion Criteria Any age group of patients with confirmed & probable diagnosis of Mucormycosis will be enrolled for this study Exclusion Criteria Any subject without a confirmed diagnosis of mucormycosis. 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 45 and 90 days Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Grade III and IV toxicities of antifungal agents Total Sample Size=300 Sample Size from =300 N/A 01/01/2016 Years=1 Months=0 Days=0 t Applicable Open to Recruitment 45 days page 5 / 7

6 Study Summary Title Multicenter observational study on epidemiology, treatment an outcome of Mucormycosis in Short Title Description of epidemiology, treatment practice and outcome mucomycosis in Protocol Number FISF Phase IV Methodology Observational study Study Duration 1 years Study Center(s) Multi-center. Objectives Primary: - To describe the epidemiology, diagnosis, treatment practices outcome of mucormycosis in 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 page 6 / 7

7 Powered by TCPDF ( PDF of Trial Study Product, Dose, Route, Regimen study product will be used as it is only observational study Duration of administration not applicable Reference therapy t applicable Statistical Methodology Descriptive and quantitative statistics page 7 / 7