| CTRI Number |
CTRI/2013/01/003333 [Registered on: 28/01/2013] Trial Registered Retrospectively |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational registry to evaluate the current clinical practice on the management of diarrhea in children |
|
Scientific Title of Study
|
Registry in the management of acute diarrhea in children: observational study in daily practice. |
| Trial Acronym |
REMAD 2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DIREGR06373 Protocol Final version 1-Dated 5-Jun-2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Keya Rani Lahiri |
| Designation |
Principal Investigator |
| Affiliation |
Dr. D.Y. Patil Medical College Hospital and Research Centre |
| Address |
Sector-5, Nerul, Navi Mumbai 400706,
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9820055685 |
| Fax |
|
| Email |
drkeyalahiri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Gayatri Jaiswal |
| Designation |
Senior Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
A-101, Business Square,
Sir Mathuradas Vasanji Marg,
Chakala, Andheri (E),
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
|
| Email |
Gayatri.Jaiswal@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Gayatri Jaiswal |
| Designation |
Senior Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
A-101, Business Square,
Sir Mathuradas Vasanji Marg,
Chakala, Andheri (E),
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707806 |
| Fax |
|
| Email |
Gayatri.Jaiswal@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Sanofi Synthelabo (India) Limited |
|
|
Primary Sponsor
|
| Name |
Sanofi Synthelabo India Limited |
| Address |
A-101, Business Square,
Sir Mathuradas Vasanji Marg,
Chakala, Andheri (E),
Mumbai – 400093
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh
Costa Rica
Dominican Republic
Egypt
El Salvador
Georgia
Guatemala
Honduras
India
Jordan
Kazakhstan
Kuwait
Lebanon
Mexico
Pakistan
Panama
Qatar
Saudi Arabia
United Arab Emirates
Uzbekistan
Venezuela (Bolivarian Republic of) |
|
Sites of Study
|
| No of Sites = 25 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Keya Rani Lahiri |
Dr. D.Y. Patil Medical College Hospital and Research Centre, |
Sector-5, Nerul, Navi Mumbai 400706
Mumbai
MAHARASHTRA |
9820055685
drkeyalahiri@gmail.com |
| Dr Shrish Bhatnagar |
Ankur Nursing Home, |
F-2314, Rajajipuram, Lucknow 226017
Lucknow
UTTAR PRADESH |
9918208555
drshrishbhatnagar@gmail.com |
| Dr Sunny Narula |
Cosmo Hospital |
Sector 62, Phase 8, Mohali, Punjab
|
9815066055
sunnyn_narula74@yaho.co.in |
| Dr Sridhar Ganapathy |
Shri Siddhi Vinayak Clinic, |
New Shopping Complex, Sec. 7, CGS Colony, Antop Hill, Mumbai 400037
Mumbai
MAHARASHTRA |
02224094199
sridhar.ganapathy@rediffmail.com |
| Dr Chetan Shah |
Anand Children Hospital |
1/568-B, Mohallo, Athugar Shreet, Opp. State Bank of India, Timaliyawad, Nanpura, Surat-395001
Surat
GUJARAT |
02612474229
anandhospital@ymail.com |
| Dr Sailesh Gupta |
Arushee Childcare Hospital, |
1st Floor, Bharati Enclave CHS Ltd., Off Link Road, Opposite Greens Restautant, Chincholi, Malad West
Mumbai
MAHARASHTRA |
9819042213
secgeniap1213@gmail.com |
| Dr S Ramesh |
BRS Hospital Pvt. Ltd., |
No. 28, Cathedral Garden Road, Nungambakkam, Chennai-600034
Chennai
TAMIL NADU |
9940676999
rameshsanthanakrishnan@gmail.com |
| Dr Rajan Joshi |
Devdatta Hospital, |
Balajinagar, Pune-Satara Road, Dhankawadi, Pune-411043
Pune
MAHARASHTRA |
9822032250
rajanvjoshi@yahoo.com |
| Dr Aniruddha Chatterjee |
Dr. Aniruddha Chatterjee |
A-17 and 18, 1st Floor, South Extension, Part 1, New Dehli 110049
New Delhi
DELHI |
9810499338
doctorforbabies@gmail.com |
| Dr D Ramesh |
Dr. D Ramesh Healing Touch Hospital |
Opp Clock Tower, Secunderabad.
Andhra Pradesh
Hyderabad
ANDHRA PRADESH |
9951969915
healing.wel@gmail.com |
| Dr Dipti Gopal |
Dr. Dipti Gopal |
Shop no. 7, UGF Arohi Complex Sec. H, Aliganj, Lucknow India
Lucknow
UTTAR PRADESH |
9044151396
drdiptigopal@gmail.com |
| Dr Nidhish Nanavaty |
Dr. Nidhish Nanavaty Clinic, |
Shubhlaxmi Complex, Opp. Sanghvi High School, Narayanpura, Ahemdabad 380013
Ahmadabad
GUJARAT |
9825166444
shubhnidhi@hotmail.com |
| Dr Pallab Chattopadhyay |
Dr. Pallab Chattopadhyay |
CA-143, Salt Lake, Sector 1, Kolkata 700064
Kolkata
WEST BENGAL |
9830178987
pallabchatterjee@gmail.com |
| Dr Pramod Jog |
Dr. Pramods Private Clinic, |
Sagar Apartment, Parihar Chowk, Near I.T.I, Aundh, Pune 411007
Pune
MAHARASHTRA |
9422309677
dr_pramodjog@yahoo.co.in |
| Dr Rajiv Chandra Mathur |
Dr. Rajiv Mathur Consulting Chamber, |
5, Subhodaya, Boggulkunta, Hyderabad 500001
Hyderabad
ANDHRA PRADESH |
9866244630
rcmathur@hotmail.com |
| Dr Satish K |
Dr. Satish’s Private Clinic |
#305, Jakkasandra Main Road, 1st block, Koramangala, Bangalore-560034
Bangalore
KARNATAKA |
9743115942
drsatish.k9270@gmail.com |
| Dr Apurba Ghosh |
Institute of Child Health |
11, Dr. Biresh Guha Street, Kolkatta-700017
Kolkata
WEST BENGAL |
9433009788
apurbaghosh@yahoo.com |
| Dr Chandra Jayakumar |
Lekshmi, |
Thamarapally Lane, Kottayam, Kerala
Kottayam
KERALA |
9446053602
dr.jayakumar@gmail.com |
| Dr Ashish Prakash |
LLRM Medical college & Hospital |
Head Of the Department, Department of Pediatrics, LLRM Medical college & Hospital, Garh Road, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH |
9810157064
ashprakash@yahoo.com |
| Dr Pankaj Vohra |
Max, Super Speciality Hospital |
2, Press Enclave Road, Saket, New Delhi-110017
New Delhi
DELHI |
01126515050
pankaj.vohra@maxhealthcare.com |
| Dr Subhasish Bhattacharyya |
Medical College Kolkata |
Department of Pediatrics, Medical College Kolkata
Kolkata
WEST BENGAL |
9830053771
dr_subhasish@yahoo.co.in |
| Dr Piyali Bhattacharya |
Sanjay Gandhi Post Graduate Institute of Medical Science |
Raebareli Road, Lucknow 226014
Lucknow
UTTAR PRADESH |
05222494754
drpiyali@gmail.com |
| Dr Sharadha Srinivas |
Seethapathy Clinic and Hospital Pvt. LTd., |
128 (241), Royapettah High Road, Chennai 600014
Chennai
TAMIL NADU |
24671760
24671760
chaaru.sharada@gmail.com |
| Dr T Prashanth Reddy |
Sun Rise Childrens Hospital |
Opposite IPM Blood Bank, Besides Baba Showroom, Narayanaguda, Hyderabad-500029
Hyderabad
ANDHRA PRADESH |
04024766363
tatikonda.prashanthreddy@gmail.com |
| Dr Ritesh V Shah |
Vraj Childrens Hospital |
101, Pushiti Smruti Appt., Opp.Suryanagar Bus Stand, Waghodia Road, Vadodara – 390019
Vadodara
GUJARAT |
2522360
riteshhira75@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 25 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum/Mumbai/Aniruddha Chatterjee |
Approved |
| Clinical Ethics Forum/Mumbai/Apurba Ghosh |
Approved |
| Clinical Ethics Forum/Mumbai/Ashish Prakash |
Approved |
| Clinical Ethics Forum/Mumbai/Chandra Jaykumar |
Approved |
| Clinical Ethics Forum/Mumbai/Chetan Shah |
Approved |
| Clinical Ethics Forum/Mumbai/D Ramesh |
Approved |
| Clinical Ethics Forum/Mumbai/Dipti Gopal |
Approved |
| Clinical Ethics Forum/Mumbai/Keya Rani Lahiri |
Approved |
| Clinical Ethics Forum/Mumbai/Nidhish Nanavaty |
Approved |
| Clinical Ethics Forum/Mumbai/Pallab Chattopadhyay |
Approved |
| Clinical Ethics Forum/Mumbai/Pramod Jog |
Approved |
| Clinical Ethics Forum/Mumbai/Rajan Joshi |
Approved |
| Clinical Ethics Forum/Mumbai/Rajiv Chandra Mathur |
Approved |
| Clinical Ethics Forum/Mumbai/Ritesh V Shah |
Approved |
| Clinical Ethics Forum/Mumbai/S Ramesh |
Approved |
| Clinical Ethics Forum/Mumbai/Sailesh Gupta |
Approved |
| Clinical Ethics Forum/Mumbai/Satish K |
Approved |
| Clinical Ethics Forum/Mumbai/Sharadha Srinivas |
Approved |
| Clinical Ethics Forum/Mumbai/Shirish Bhatnagar |
Approved |
| Clinical Ethics Forum/Mumbai/Sridhar Ganapathy |
Approved |
| Clinical Ethics Forum/Mumbai/Subhasish Bhattacharyya |
Approved |
| Clinical Ethics Forum/Mumbai/Sunny Narula |
Approved |
| Clinical Ethics Forum/Mumbai/T Prashant Reddy |
Approved |
| Institutional EC/Lucknow/Piyali Bhattacharya |
Approved |
| Max Healthcare EC/New Delhi/Pankaj Vohra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Childhood acute diarrhea., (1) ICD-10 Condition: R197||Diarrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
•Infants or children presenting with acute diarrhea acquired in the community,
• Aged between 6 months to 6 years old,
• Children with acute diarrhea evident for less than 48 hours whatever the origin,
• Children who had ≥ 3 watery stools during the preceding 24 hours,
• Children whose parents or legal guardians have given their written informed
consent. |
|
| ExclusionCriteria |
| Details |
Children suffering from a chronic disease [Crohn’s Disease, Hemorrhagic rectocolitis,
IBS),
• Parents or legal guardians unable to fill diary card.
• Children suffering from severe malnutrition and/or immuno-compromised
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To describe the current “real life†management of childhood acute diarrhea in developing countries/regions.
|
At the time of end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To country/local specificities that may determine some therapeutic decisions /
o Type of center,
o Medication availability/cost,
o Laboratory tests,
o Traditions,
o Geographical constrains….
2. To generate epidemiological data on the different types of diarrhea in these countries/regions.
|
At the time of end of the study |
|
|
Target Sample Size
|
Total Sample Size="3750"
Sample Size from India="500"
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)
|
01/01/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2012 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
International, prospective, longitudinal [V1 + 15 days
follow-up time], observational, non-comparative, multi-center registry in
children with acute diarrhea. This registry is non-interventional on the
therapeutic strategy.
Study duration per patient: 1 visit, followed by one
longitudinal follow-up visit at 15 (±1) days.
The purpose of the REMAD 2 Registry is to collect
information about children with acute diarrhea. The goal of this observational
registry is to evaluate the current clinical practice on the management of
diarrhea in children.
|