| CTRI Number |
CTRI/2023/11/060346 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical and laboratory characteristics and health seeking behavior in patients with dengue in India |
|
Scientific Title of Study
|
Improved data on Dengue covering differences in epidemiological surveillance, patient demographics, the health seeking behavior of patients and standards of care |
| 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 Kavita Singh |
| Designation |
Director |
| Affiliation |
DNDi South Asia Pvt. Ltd |
| Address |
A-15 Second Floor
Hauz Khas
New Delhi
South West DELHI 110016 India |
| Phone |
919818629809 |
| Fax |
|
| Email |
ksingh@dndi.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kavita Singh |
| Designation |
Director |
| Affiliation |
DNDi South Asia Pvt. Ltd |
| Address |
A-15 Second Floor
Hauz Khas
New Delhi
South West DELHI 110016 India |
| Phone |
919818629809 |
| Fax |
|
| Email |
ksingh@dndi.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Kavita Singh |
| Designation |
Director |
| Affiliation |
DNDi South Asia Pvt. Ltd |
| Address |
A-15 Second Floor
Hauz Khas
New Delhi
South West DELHI 110016 India |
| Phone |
919818629809 |
| Fax |
|
| Email |
ksingh@dndi.org |
|
|
Source of Monetary or Material Support
|
| Drugs for Neglected Diseases Initiative South Asia Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
Drugs for Neglected Diseases Initiative South Asia Pvt. Ltd |
| Address |
A 15 Second Floor
Hauz Khas
New Delhi |
| Type of Sponsor |
Other [Industry partner] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pratibha Pereira |
JSS Medical College and Hospital |
Department of Geriatrics, JSS Medical College and Hospital, Mahatma Gandhi Road, Ramchandra Agrahara Mysore KARNATAKA |
919448282506
ppatta08@gmail.com |
| Dr Avinash Agrawal |
King George Medical University |
Department of Critical Care Medicine, King Georges Medical University, Shah Mina Road Chowk
Lucknow UTTAR PRADESH |
919838677999
avinashagrawal@kgmcindia.edu |
| Dr Satyajit Mohapatra |
SRM Medical College Hospital and Research Centre |
SRM Centre For Clinical Trials and Research
SRM Medical College Hospital and Research Centre
SRM Nagar
Potheri Kancheepuram TAMIL NADU |
919791161626
satyajim@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee JSS Medical College and Hospital |
Approved |
| Institutional Ethics Committee King George Medical University |
Approved |
| Institutional Ethics Committee SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Part A
All patients who are hospitalized with a suspected/confirmed acute dengue and who are capable of participating and providing consent will be recruited following informed written consent
Part B
Patients with a febrile illness and suspected to have acute dengue presenting to a primary health care facility OR outpatient facility OR community center of the study sites who are capable of participating and providing consent will be recruited following informed written consent |
|
| ExclusionCriteria |
| Details |
Part A
Patient refusal to participate
Part B
Patient refusal to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To collect data on dengue covering differences in epidemiological data, patient demographics, the health seeking behavior of patients and standards of care across different regions in India |
Part A
Data collection at the time when a dengue patient admitted to the hospital is recruited in the study and subsequently at discharge
Part B
Data collection at a single time point when febrile patient with suspected dengue presents to the OPD or the primary health centre and is enrolled in the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="316" Sample Size from India="316"
Final Enrollment numbers achieved (Total)= "316"
Final Enrollment numbers achieved (India)="316" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2023 |
| Date of Study Completion (India) |
31/03/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Observational multicentric study has been planned to address the dengue related knowledge gaps by collecting data covering differences in epidemiological surveillance, patient demographics, the health seeking behavior of patients and standards of care for dengue across different clinical sites in India. The study has been planned in 2 parts. 1. To determine the number of patients with dengue fever admitted to one or more hospitals in India during a period of 3 months or more if sample size requirements are not met 2. To characterize the age, gender, clinical features, complications and clinical disease severity of patients with acute dengue presenting to healthcare facilities in India. 3. To determine the proportion of admitted patients with acute dengue who have comorbidities (diabetes, obesity, hypertension, sickle cell disease) 4. To determine the proportion of admitted patients with dengue that required admission to intensive care units and the reasons for the same along with associated mortality. 5. To determine the duration of hospital stay in patients admitted to a hospital with acute dengue 1. To determine the number of patients with suspected acute dengue presenting to a primary health care facility/outpatient facility/community centers/other health care settings in India in a three-month period (extendable if required) between October 2023 to May 2024. 2. To characterize the age, gender, clinical features, complications and clinical disease severity of patients with suspected acute dengue presenting at these sites 3. To identify the duration of illness when seeking medical advice and reasons for presenting late/early 4. To determine the knowledge about dengue warning signs and risk factors for severe disease (diabetes, obesity, pregnancy, old age etc.) 5. To find out the type of treatment taken prior to seeking medical advice (herbal remedies, paracetamol, NSAIDs and other OTCs) Part A: All patients who are hospitalized with acute dengue and who are capable of participating and providing consent will be recruited following informed written consent. The study will be carried out in 3 tertiary care hospitals in India. Part B: Patients with a febrile illness and suspected to have acute dengue will be recruited in 2-3 PHC/CHC/UHTC/RHTC associated with the tertiary care hospitals participating in Part A of the study. Also, the study will be conducted in the OPDs of the selected tertiary care hospitals in Part A of the study proposal. The patients will be recruited following informed written consent.
A pre-tested and structured interviewer-administered questionnaire will be used to record requisite patient related details. Complete patient data confidentiality will be maintained. A validated data management tool will be used to collect all patient-related information. Descriptive statistics will be used to analyze subject data. |