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CTRI Number  CTRI/2021/10/037230 [Registered on: 11/10/2021] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Hybrid surveillance 
Study Design  Other 
Public Title of Study   Incidence of severe enteric fever in India 
Scientific Title of Study   Hybrid surveillance for incidence of severe enteric fever in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gagandeep Kang 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162282052  
Fax    
Email  gkang@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gagandeep Kang 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162282052  
Fax    
Email  gkang@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gagandeep Kang 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162282052  
Fax    
Email  gkang@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Bill and Melinda Gates Foundation, 500 5th Ave N, Seattle, WA 98109, USA 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Christian Medical College, Ida Scudder road, Vellore - 632004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jacob John  Christian Medical College, Vellore  The Wellcome Trust Research Laboratory,Division of Gastrointestinal Sciences AND Department of Community Health, Christian Medical College,Vellore - 632004
Vellore
TAMIL NADU 
9442631628

jacob@cmcsph.org 
Dr Madhu Gupta  Post Graduate Institute of Medical Education and Research, Chandigarh  Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh - 160012
Chandigarh
CHANDIGARH 
7087008223

madhugupta21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Review Board (IRB), Christian Medical College, Vellore  Approved 
Postgraduate Institute of Medical Education and Research Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:A010||Typhoid fever. Ayurveda Condition: fever,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients presenting to study hospitals with a history of fever
2. Patients residing in the study area 
 
ExclusionCriteria 
Details  Patients
1. who do not consent to the study
2. Diagnosed with malignancies
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Annual incidence of severe typhoid and paratyphoid fever in Vellore and Chandigarh cities  at 2 years from study initiation 
 
Secondary Outcome  
Outcome  TimePoints 
To describe clinical presentation and course of illness in patients with culture confirmed enteric fever  At 2 years after initiation of the study 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jacob@cmcsph.org].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Under the Surveillance for enteric fever in India project done between 2017-20, urban areas of Vellore and Chandigarh were found to have a high burden of typhoid fever. While the incidence of typhoid was estimated as 12 per 1000 person-years (PY) in Vellore using a cohort-based approach, Chandigarh noted comparable estimates of about 10 cases per 1000 PY. Since the incidence of typhoid fever varies considerably over time and across settings, continued surveillance is necessary to establish the burden. Cohort studies, while offering good approaches to uncover ongoing transmission, are not optimal for establishing the severity of disease as the active surveillance results in early treatment, and thus bias to milder disease. Hybrid surveillance is an alternative approach that estimates the incidence of more severe enteric fever by combining hospital-based surveillance with healthcare utilization by the community and are significantly less resource-intensive. Using this approach, we will prospectively undertake blood culture surveillance for febrile admissions at hospitals that account for at least 60% of all febrile admissions in the reference population. Health care utilization pattern of the study population for fever-related hospitalizations during the study period will be captured using bi-annual healthcare utilization surveys (HCUS) as Covid-19 may influence healthcare utilization over time.

 We will estimate the crude incidence of blood-culture-confirmed enteric fever by dividing the number of cases of enteric fever identified in the population at risk. These crude incidence estimates will be adjusted for healthcare utilization patterns observed in the bi-annual HCUS, the proportion of febrile admissions that received blood culture and the diagnostic accuracy blood culture (sensitivity), to arrive at the adjusted incidence of enteric fever. In addition, we will characterize the severity of enteric fever presenting at these facilities and estimate the proportion of enteric fevers that present to healthcare facilities but are managed as ambulatory patients

 
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