CTRI Number |
CTRI/2017/09/009719 [Registered on: 12/09/2017] Trial Registered Prospectively |
Last Modified On: |
20/03/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
Burden of typhoid fever in India |
Scientific Title of Study
|
National Surveillance System for Enteric Fever in India |
Trial Acronym |
NSSEFI |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Gagandeep Kang |
Designation |
Professor |
Affiliation |
Christian Medical College |
Address |
Wellcome Research Laboratory
Christian Medical College Vellore Department of Gastrointestinal Sciences
Christian Medical College Vellore Vellore TAMIL NADU 632002 India |
Phone |
04162282052 |
Fax |
09442631628 |
Email |
gkang@cmcvellore.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Gagandeep Kang |
Designation |
Professor |
Affiliation |
Christian Medical College |
Address |
Wellcome Research Laboratory
Christian Medical College Vellore Department of Gastrointestinal Sciences
Christian Medical College Vellore
TAMIL NADU 632002 India |
Phone |
04162282052 |
Fax |
09442631628 |
Email |
gkang@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Gagandeep Kang |
Designation |
Professor |
Affiliation |
Christian Medical College |
Address |
Wellcome Research Laboratory
Christian Medical College Vellore Department of Gastrointestinal Sciences
Christian Medical College Vellore
TAMIL NADU 632002 India |
Phone |
04162282052 |
Fax |
09442631628 |
Email |
gkang@cmcvellore.ac.in |
|
Source of Monetary or Material Support
|
Bill and Melinda Gates Foundation,
500 Fifth Avenue North
Seattle, WA 98109
United States of America |
|
Primary Sponsor
|
Name |
Christian Medical College |
Address |
Ida Scudder Road
Vellore |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 4 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Temsunaro RongsenChandola |
Centre for Health Research and Development |
Society for Applied Studies
Kalu Sarai South West DELHI |
9810804824
naro@sas.org.in |
Jacob John |
Christian Medical College |
Department of Community Medicine,Bagayam Campus Vellore TAMIL NADU |
9442631628
jacob@cmcsph.org |
Ashish Bavdekar |
KEM Hospital Research Centre, Pune |
Department of Pediatrics,
489, Sardar Moodliar Road, Rasta Peth,411011 Pune MAHARASHTRA |
982205617
bavdekar@vsnl.com |
Shanta Dutta |
National Institute of Cholera and Enteric Diseases |
C.I.T. Scheme XM, Beleghata Kolkata WEST BENGAL |
03323632398
shanta1232001@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 4 |
Name of Committee |
Approval Status |
Jamia Hamdard Institutional Ethics Committee |
Approved |
Christian Medical College Vellore |
Approved |
KEM Hospital and Research Centre |
Approved |
NICED Institutional Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Enteric Fever, (1) ICD-10 Condition: A010||Typhoid fever, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
6.00 Month(s) |
Age To |
15.00 Year(s) |
Gender |
Both |
Details |
Resident in study area for the duration of study |
|
ExclusionCriteria |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Culture confirmed Typhoid fever |
At the end of 24 months of follow up |
|
Secondary Outcome
|
Outcome |
TimePoints |
Culture confirmed Paratyphoid fever |
At 24 months of follow up |
|
Target Sample Size
|
Total Sample Size="24000" Sample Size from India="24000"
Final Enrollment numbers achieved (Total)= "24000"
Final Enrollment numbers achieved (India)="24000" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
18/09/2017 |
Date of Study Completion (India) |
02/03/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
02/03/2020 |
Estimated Duration of Trial
|
Years="2" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
10.1056/NEJMoa2209449 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The objectives of this community-based surveillance component of the National Surveillance System for Enteric Fever in India are to estimate the burden of culture confirmed typhoid and paratyphoid fever in the community; describe the incidence of acute febrile illness and its associated treatment practices in the community and to explore the risk factors for typhoid transmission in the community to permit the risk characterisation of the settings where the incidence estimates arise from. The study will be conducted in four states in various locations of India (Tamil Nadu, Maharashtra, Delhi and West Bengal). Children from Urban/semi urban populations at these sites will be enrolled. Each site will enrol 6000 children in approximately four months’ time and follow them up for 24 months. At each site incident cases of fever will be identified through weekly fever surveillance and self-reporting of febrile episodes. Additionally, specific sites may use other systems relevant to their setting for example monitoring hospitals within the surveillance setting for identification of fever cases. Fever episodes will be followed up daily until the end of the episode by dedicated field research personnel. Any febrile episode meeting the criteria for suspected typhoid fever will be encouraged to provide a blood sample for diagnosis of typhoid fever. Treatment will be continued at the preferred healthcare provider. Early use of unwarranted antibiotics, especially prior to investigation of suspected typhoid fever will be minimized using a combination of approaches tailored to each study setting. Suspected typhoid fever will be investigated using blood culture in an automated blood culture system. Isolates will be sequenced at a central laboratory to identify the genotypic characteristics. |