| CTRI Number |
CTRI/2025/12/099334 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate a New Rapid Blood Test for Detecting Dengue Infection among Suspected Dengue Patients in Thiruvallur District, Tamil Nadu. |
|
Scientific Title of Study
|
Molecular Diagnostic Accuracy and Novel Detection of Dengue Virus Using an NS2 Gene–Based Reverse Transcription Loop-Mediated Isothermal Amplification Assay |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rubina Mary |
| Designation |
MD Community Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Tata santorini Block Korfos A-203 No451 kuthambakkam village, padur road poonamallee Chennai 600124
Saveetha Nagar Saveetha Medical College and Hospital Thandalam, Chennai 602105
Kancheepuram
TAMIL NADU
636002
India |
| Phone |
9585536633 |
| Fax |
|
| Email |
rubinamary07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rubina Mary |
| Designation |
MD Community Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Tata santorini Block Korfos A-203 No451 kuthambakkam village, padur road poonamallee Chennai 600124
Saveetha Nagar Saveetha Medical College and Hospital Thandalam, Chennai 602105
Kancheepuram
TAMIL NADU
636002
India |
| Phone |
9585536633 |
| Fax |
|
| Email |
rubinamary07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rubina Mary |
| Designation |
MD Community Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Tata santorini Block Korfos A-203 No451 kuthambakkam village, padur road poonamallee Chennai 600124
Saveetha Nagar Saveetha Medical College and Hospital Thandalam, Chennai 602105
Kancheepuram
TAMIL NADU
636002
India |
| Phone |
9585536633 |
| Fax |
|
| Email |
rubinamary07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RUBINA MARY |
| Address |
Tata santorini Block Korfos A-203 No451 kuthambakkam village, padur road poonamallee Chennai 600124 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rubina Mary |
Department of Community Medicine ,Saveetha medical college and hospital |
Saveetha medical college and hospital , saveetha nagar thandalam , sriperumbadur , Chennai 602105
Chennai
TAMIL NADU |
9585536633
rubinamary07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMCH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B970||Adenovirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEN-LAMP KIT |
Molecular Diagnostic Accuracy and Novel Detection of Dengue Virus Using an NS2 Gene–Based Reverse Transcription Loop-Mediated Isothermal Amplification Assay in 1 year duration |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Clinically suspected dengue patients of both genders aged 0 to 65 years, as identified and referred by clinicians for laboratory investigation.
Written informed consent will be obtained from participants aged above 18 years.
For participants aged less than 18 years, written informed consent from parents or legally authorized guardians will be obtained, with assent from the child wherever applicable |
|
| ExclusionCriteria |
| Details |
Unsuspected Dengue patients and participants who could not provide informed consent will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the diagnostic accuracy of the NS2 gene–based RT-LAMP assay (DEN-LAMP) for detection of dengue virus in clinically suspected dengue patients, as measured by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), using conventional RT-PCR as the reference standard. |
Baseline (0–7 days from fever onset) Primary outcome (sensitivity,specificity,PPV,NPV) assessed using samples collected during the acute febrile phase (within 7 days of symptom onset), with DEN-LAMP compared against RT-PCR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time to detection of dengue virus using the DEN-LAMP assay with conventional RT-PCR and assess its turnaround time.
To evaluate the analytical and operational performance of DEN-LAMP, including limit of detection, reproducibility, and ease of use in a routine laboratory setting.
To compare the cost per test and assess the agreement between DEN-LAMP and RT-PCR results using appropriate statistical measures (e.g., kappa statistic) |
secondary outcomes will be assessed at baseline (Day 0–1) during laboratory processing of the same clinical specimen and throughout the study period for analytical performance parameters (limit of detection and reproducibility). |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to evaluate the diagnostic accuracy of a novel NS2 gene based reverse transcription loop mediated isothermal amplification assay for detection of dengue virus. Clinically suspected dengue patients aged 0 to 65 years will be included and clinical samples will be tested using the DEN LAMP assay and compared with conventional RT PCR as the reference standard. The study will assess sensitivity specificity predictive values time to detection analytical performance operational feasibility cost per test and agreement between the two methods to determine the usefulness of DEN LAMP as a rapid and feasible diagnostic tool for dengue infection. |