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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 

Study Objectives: 

Part A 

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 

 

Part B   

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)  

 

Methodology 

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.  

 
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