REF/2014/07/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Mon, 01 Jan :09:26 GMT) CTRI Number Last Modified On 18/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/08/ [Registered on: 11/08/2014] - Trial Registered Prospectively No Observational A multinational prospective study Other A study to describe treatment and outcome in patients with diarrhea caused by bacteria Clostridium difficile in Asian Pacific countries A Prospective Study to Characterize the Management and Outcome of Clostridium difficile Infection in Asian Pacific Countries. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) NIL NIL Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Annappa Kamath Phone Fax Portfolio Director - PORTFOLIO LEADERSHIP Group PAREXEL International Clinical Research Private Limited Plot # 180, 3rd Floor, MFAR Silverline Tech Park, EPIP II Phase, Whitefield, Bangalore , Karnataka,. Bangalore Annappa.Kamath@parexel.com Details Contact Person (Public Query) Dr Annappa Kamath Phone Fax Portfolio Director - PORTFOLIO LEADERSHIP Group PAREXEL International Clinical Research Private Limited Plot # 180, 3rd Floor, MFAR Silverline Tech Park, EPIP II Phase, Whitefield, Bangalore , Karnataka,. Bangalore page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Source of Monetary or Material Support > Otsuka Pharmaceutical Co., Ltd. 2-9 Kanda-Tsukasamachi, Chiyoda-ku Tokyo, Japan Type of Sponsor PAREXEL International Clinical Research Private Limited List of Countries Australia China Hong Kong Indonesia Japan Malaysia Philippines Republic of Korea Singapore Taiwan Thailand Viet Nam of Principal Investigator Dr Pravin Shivaji Gare DrRaja Nagarjuna Kumar Yarlagadda Dr Srinivasa Madaiah DrPhilip Abraham Primary Sponsor Details Otsuka Pharmaceutical Co Ltd 2-9 Kanda-Tsukasamachi, Chiyoda-ku Tokyo, Japan Pharmaceutical industry-global Plot # 180, 3rd Floor, MFAR Silver Line Techpark, EPIP II Phase, Whitefield, Bangalore , Karnataka,. of Site Site Phone/Fax/ Chopda Medicare & Research Centre Pvt. Ltd. Krishna Institute Of Medical Sciences Mysore Medical College & Research Institute P.D. Hinduja National Hospital and Medical Research Centre Magnum Heart Institute, Patil Lane No.1 Canada Corner, Pin drpravingare@rediffmail Code ,..com Nashik MAHARASHTRA Block-2,3rd Floor, Department of Medical Gastro, /1, Minister Road, Secunderbad , INDIA. Hyderabad ANDHRA PRADESH Department of General Medicine, 1st Floor, Next to Control Room, K. R. Hospital, Irwin Road, Pin Code , Mysore Division Of Gastroenterology, Room#1104, Hinduja nagarjunayarlagadda20 20@gmail.com drsrinivasam@gmail.co m dr_pabraham@hinduja page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Clinic Veer Savarkar Marg, Mahim, Pin Code ,. Mumbai MAHARASHTRA hospital.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee, Mysore and Research Institute and Associated Hospitals, Mysore , Karnataka, Approved 16/04/2014 No Institutional Ethics Committee, P.D.Hinduja National Hospital And Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai , Maharashtra, KFRC Ethics Committee, #1-8-31/1, Minister Road, Secunderabad , Andhra Pradesh, Magna-care Ethics Committee, C/o Chopda Medicare & Research Centre Pvt. Ltd., Magnum Heart Institute, Patil Lane No.1, Canada Corner, Nasik , Maharashtra, Status Health Type Patients Approved 15/07/2014 No Approved 25/04/2014 No Approved 07/06/2014 No Date No Date Specified Condition Clostridium difficile Infection Type Details Age From Age To Gender Details Details 0.00 Day(s) Year(s) Both Inclusion Criteria Patients must meet the following criteria in order to be enrolled in the study: Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for CDT or toxigenic C. difficile, or colonoscopic findings of PMC Patients and/or legal guardian willing to provide informed consent and/or informed assent or data release, according to local regulations. Exclusion Criteria Patients who meet the following criteria will not be enrolled in the page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking study: Patients with diarrheal symptoms caused by bacteria other than C. difficile, such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli. Primary Outcome Outcome Timepoints To assess the characteristics of patients with CDI in terms of patient demographics, medical history, prior and concomitant medications, including antimicrobial agents, clinical laboratory data, and disease characteristics To describe the diagnosis, management and treatment regimen(s) of patients with CDI To describe clinical outcomes of CDI patients, including recurrence of CDI To obtain the stool sample from the patients with CDI for further analysis. Throughout the study 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 Status at the end of CDI episode (e.g., complete resolution of CDI) Clinical complications and date of onset/occurrence: Dehydration, Hypokalemia, Toxic megacolon, Colonic perforation, Peritonitis, Fulminant colitis, Septic shock, Emergency colectomy or other related procedure, Other, specify, Mortality, Date of death, Primary cause of death Recurrence, Date of recurrence, Duration of recurrence, Severity of recurrent CDI, Medication for treatment, Final outcome of recurrent case Total Sample Size=627 Sample Size from =48 N/A 16/08/ /04/2014 Years=0 Months=4 Days=24 Closed to Recruitment of Participants From CDI diagnosis until end of the CDI episode Throughout the study After 2 months follow up of final outcome by telephone page 4 / 5

5 Powered by TCPDF ( REF/2014/07/ Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Closed to Recruitment of Participants Observational study of practical treatment practices in Clostridium Difficile Infection patient population. Protocol does not recommend the use of any specific treatments. No study medication is provided as part of participation. Treatment (e.g., vancomycin, metronidazole) for Clostridium Difficile Infection will be collected in order to describe clinical outcomes page 5 / 5

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - CTRI Website URL http://ctri.nic.in Clinical Trial Details (PDF Generation Date : Tue, 29 Jan 2019 00:44:06 GMT) CTRI Number Last Modified On 29/01/2013 Post Graduate Thesis Type of Trial Type of Study