| CTRI Number |
CTRI/2012/03/002475 [Registered on: 05/03/2012] Trial Registered Retrospectively |
| Last Modified On: |
27/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Epidemiology Study |
| Study Design |
Other |
|
Public Title of Study
|
A Multicenteric study to estimate the burden of rotavirus gastroenteritis among hospitalization due to diarrhea. |
|
Scientific Title of Study
|
A Multicenter prospective hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children less than five years of age in India. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SBL/BRV-TV/004 v1.0 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep Singh Dhingra |
| Designation |
Chief Clinical, PV and CQA Officer |
| Affiliation |
Shantha Biotechnics Limited |
| Address |
Shantha Biotechnics Limited, 3rd and 4th Floor,
Vasantha Chambers, #5-10-173, Fateh Maidan Road,
Basheer Bagh, Hyderabad.
Hyderabad
ANDHRA PRADESH
500004
India |
| Phone |
40-66301000 |
| Fax |
40-23234133 |
| Email |
drmandeep@shanthabiotech.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep Singh Dhingra |
| Designation |
Chief Clinical, PV and CQA Officer |
| Affiliation |
Shantha Biotechnics Limited |
| Address |
Shantha Biotechnics Limited, 3rd and 4th Floor,
Vasantha Chambers, #5-10-173, Fateh Maidan Road,
Basheer Bagh, Hyderabad.
Hyderabad
ANDHRA PRADESH
500004
India |
| Phone |
40-66301000 |
| Fax |
40-23234133 |
| Email |
drmandeep@shanthabiotech.co.in |
|
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Source of Monetary or Material Support
|
| Shantha Biotechnics Limited |
|
|
Primary Sponsor
|
| Name |
Shantha Biotechnics Limited |
| Address |
Shantha Biotechnics Limited, 3rd and 4th Floor,
Vasantha Chambers, #5-10-173, Fateh Maidan Road,
Basheer Bagh, Hyderabad. 500004. AP, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anurag Chaudhary |
Dayanand Medical College & Hospital |
Department of Community Medicine
Dayanand Medical College & Hospital
Ludhiana-141001, Punjab, India
Ludhiana
PUNJAB |
01614686600
anuragdmc@yahoo.co.in |
| Dr J Venkateswara Rao |
Gandhi Medical College and Gandhi Hospital. |
• Professor & Head Department of Pediatrics,
Gandhi Medical College and Gandhi Hospital.
Hyderabad
Hyderabad
ANDHRA PRADESH |
04027502742
dr_jvrao@yahoo.co.in |
| DrMaria Da Piedade Silveria |
Goa Medical College |
Department of Pediatrics,
Goa Medical College,
Bambolim, Goa-403202 India
North Goa
GOA |
09422062878
mimisil@hotmail.com |
| Dr Ritabrata Kundu |
Institute Of Child Health, |
Department of Pediatrics
Institute Of Child Health,
Kolkata-700017
Kolkata
WEST BENGAL |
2290-5686
rkundu@gmail.com |
| Dr M D Ravi |
J S S Medical College and Hospital |
Department Of Pediatrics,
J S S Medical College and Hospital, Mysore, - 570004.
Mysore
KARNATAKA |
0821-2563845
larks@airtelmail.in |
| Dr Ashok Kumar Dutta |
Kalawati Saran Childrens Hospital |
Department of Pediatrics,
Lady Harding medical College and Kalawati Saran Childrens Hospital,
New Delhi-110 001
New Delhi
DELHI |
011-23365792
harishpemde@gmail.com |
| Dr Sonali Kar |
Kalinga Institute of Medical Sciences |
Department of Community Medicine,
Kalinga Institute of Medical Sciences (KIMS
Bhubaneswar-751024
Baleshwar
ORISSA |
0674-272522891
sonsam72@yahoo.co.uk |
| Dr Veena G Kamath |
Kasturba Medical College |
Dept. Of Community Medicine,
Kasturba Medical College,
Manipal, Karnataka,
India. Pin no- 576104.
Udupi
KARNATAKA |
08202571201
venkamath@yahoo.com |
| Dr S R Keshava Murthy |
Kempegowda Institute of Medical Sciences |
Department of Pediatrics,
Kempegowda Institute of Medical Sciences,
Bangalore, Karnataka
Bangalore
KARNATAKA |
08026715790
docsrk@yahoo.co.in |
| Dr JV Singh |
King George Medical College |
Department of Community Medicine and Public Health
King George Medical College, C.S.M Medical University
Lucknow ,UP
Lucknow
UTTAR PRADESH |
522-2257450
jvsingh510@yahoo.com |
| Dr Madhu Gupta |
Post Graduate Institute of Medical Education & Research |
Department of Community Medicine,
School of Public Health,
Post Graduate Institute of Medical Education & Research (PGIMER),
Chandigarh- 160012
Chandigarh
CHANDIGARH |
01722755223
madhugupta21@gmail.com |
| Dr SD Sharma |
SMS Medical College& attached Hospitals |
Department of Pediatrics,
SMS Medical College& attached Hospitals,
J.L.N. Marg, Jaipur-302004,Rajasthan
Jaipur
RAJASTHAN |
0141-2619020
sdsharmajp@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Dayanand Medical College & Hospital |
Approved |
| Gandhi Medical College and Gandhi Hospital |
Approved |
| Goa Medical College |
Approved |
| Institute Of Child Health |
Approved |
| J S S Medical College and Hospital |
Approved |
| Kalawati Saran Childrens Hospital |
Approved |
| Kalinga Institute of Medical Sciences |
Approved |
| Kasturba Medical College |
Approved |
| Kempegowda Institute of Medical Sciences |
Approved |
| King George Medical College |
Approved |
| Post Graduate Institute of Medical Education & Research |
Approved |
| SMS Medical College& attached Hospitals |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hospital-based surveillance of rotavirus gastroenteritis in children ≤ 59 months of age , |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
• All children less than and equal to 59 months of age presenting with acute gastroenteritis and requiring hospitalization with rehydration for atleast six hours.
•parents/guardians willing to give informed consent
|
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Hospitalization due to Rota virus diarrhea |
Hospitalization,at least for 6 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of diarrheal episodes |
NA |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2011 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Study involves hospital-based surveillance of rotavirus gastroenteritis in children ≤ 59 months of age. A stool sample from eligible child with acute gastroenteritis who is admitted to a participating hospital will be tested for the presence of rotavirus. The study would be conducted in a well-defined population to allow calculation of the incidence of hospitalization, the principal measure of disease burden. In order to determine the genotypes present from among the rotavirus-positive stool samples, the samples would be transported to a central laboratory at Department of Gastrointestinal Sciences, Christian Medical College, Vellore. The reported cases of rotavirus diarrhea would be characterized by place or time for children living in the referral population |