| CTRI Number |
CTRI/2025/07/090539 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Longitudinal study on dengue and Zika infections in Kerala |
|
Scientific Title of Study
|
Profiling the clinico-epidemiological, genomic, and immunological markers of dengue and Zika infections and co-infections in Kerala, India via longitudinal studies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DENZ_Protocol version V. 2.1, Date: 12-03-2025 |
Protocol Number |
| Longi_Denv_Zikv |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju Rahi |
| Designation |
Scientist G and Director |
| Affiliation |
Indian Council of Medical Research Vector Control Research Centre |
| Address |
Indian Council of Medical Research Vector Control Research Centre
INDIRA NAGAR GORIMEDU
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9999002837 |
| Fax |
|
| Email |
drmanjurahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Rahi |
| Designation |
Scientist G and Director |
| Affiliation |
Indian Council of Medical Research Vector Control Research Centre |
| Address |
Indian Council of Medical Research Vector Control Research Centre
INDIRA NAGAR GORIMEDU
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9999002837 |
| Fax |
|
| Email |
drmanjurahi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arya Rahul |
| Designation |
Scientist C |
| Affiliation |
ICMR - Vector Control Research Centre |
| Address |
Dept of Clinical and Molecular Medicine,
Room no: 12,
Indian Council of Medical Research-Vector Control Research Centre
INDIRA NAGAR GORIMEDU
Puducherry
Indira Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8148525551 |
| Fax |
|
| Email |
aryaasp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Wellcome Trust |
| Address |
Gibbs Building
215 Euston Road
London NW1 2BE
UK |
| Type of Sponsor |
Other [Biomedical research funding agency] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju Rahi |
Governmnet medical college, and SAT hospital Thiruvananthapuram, |
Department of ifectious diseases, Government medical college, Ulloor - Akkulam Road, Junction, near SAT hospital, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA |
9999002837
drmanjurahi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee ICMR VCRC Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients meeting the WHO probable dengue case definition 2009 or the WHO suspected Zika case definition 2016 with symptom onset including fever within the past five days.
Patients willing to provide informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients who is not willing to give informed written consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| immune correlates of primary and secondary dengue and zika infections and co-infections |
Day 1, 3 and 28 of onset of illness |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dengue & zika burden, clinical features, severity pattern, maternal & neonatal outcomes, genomics of virus, Aedes mosquito bionomics & infection |
patients will be followed up on 3rd & 28th day of illness to assess the clinical outcomes. Vector studies will be done every month to capture seasonal variations |
|
|
Target Sample Size
|
Total Sample Size="28000"
Sample Size from India="28000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Probable cases as defined by the WHO 2019 case definition will be recruited for the study to assess clinical manifestations with a particular focus on co infections. Since this is a hospital based study recruitment will be conducted from the outpatient department of a primary health centre. Eligible patients will be approached and those providing written informed consent will be enrolled. Recruitment will continue until the required sample size is achieved.
|