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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Enteric Fever, (1) ICD-10 Condition: A010||Typhoid fever,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
Details  non consent 
 
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.
 
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