| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A010||Typhoid fever. Ayurveda Condition: fever, |
|
|
Intervention / Comparator Agent
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jacob@cmcsph.org].
- 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.
- 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 |