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CTRI Number  CTRI/2020/02/023617 [Registered on: 27/02/2020] Trial Registered Prospectively
Last Modified On: 25/02/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Disease Profile of Dengue Fever in AIIMS Rishikesh (DPDF study) 
Scientific Title of Study   To study the Disease Profile of Dengue Fever in patients at AIIMS, Rishikesh with focus on the demographical, clinical, laboratory, treatment, and outcome variables – a cross-sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasan Kumar Panda 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh 
Address  Department of General Medicine, Sixth Floor, College Block, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Prsan Kumar Panda 
Designation  Assistant Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of General Medicine, Sixth Floor, College Block, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prasan Kumar Panda 
Designation  Assistant Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of General Medicine, Sixth Floor, College Block, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Rishikesh, Uttarakhand, 249203 
 
Primary Sponsor  
Name  AIIMS Rishikesh  
Address  Research cell, AIIMS, Rishikesh, Uttarakhand, 249203  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NILL  NILL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasan Kumar Panda  AIIMS  Department of General Medicine, Sixth Floor, College Block, Rishikesh
Dehradun
UTTARANCHAL 
9868999488

prasan.med@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Rishikesh   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 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All serological positive dengue cases (both children and adult) for next two years
2. Clinical diagnosis of dengue
3. Patient medical records available from July 2017 to present time for retrospective cohort
 
 
ExclusionCriteria 
Details  1. Positive cases who have been admitted in other than medicine/pediatric dept where medicine/padiatric reference has not been sorted respectively 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To describe the demographical, clinical, laboratory, treatment, and outcome details of dengue fever patients at AIIMS
2. To describe expanded dengue syndrome variants in same cohort
3. To determine Himalayan and sub-himalayan variation in same cohort
4. To determine the predictors of morbidity and mortality in same cohort 
Selection of cases: From July 2017 to present time for retrospective cases and for next 2-years for prospective cases  
 
Secondary Outcome  
Outcome  TimePoints 
None 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/03/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   1. WHO Dengue: Guideline for Diagnosis, Treatment, Prevention and control. 2009. /publications/2009/9789241547871_eng.pdf. Accessed August 10, 2019. 2. Wilder-Smith A, Schwartz E. Dengue in Travelers. N Engl J Med 2005;353(9):924–32. 3. Balkrishnan A, Panda PK, Wig N, et al. Compliance of WHO guideline on dengue management among Indian patients: an interventional quality improvement study. Journal of the Association of Physicians of Indian 2019;67(4):30-34. 4. Lee LK, Thein TL, Kurukularatne C, Gan VC, Lye DC, Leo YS. Dengue knowledge, attitudes, and practices among primary care physicians in Singapore. Ann Acad Med Singapore 2011;40(12):533–8. 5. Ganeshkumar P, Murhekar MV, Poornima V, Saravanakumar V, Sukumaran K, Anandaselvasankar A, et al. Dengue infection in India: A systematic review and meta-analysis. PLoS Negl Trop Dis 2018;12(7):e0006618. /10.1371/journal.pntd.0006618.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Justification for study:
Hundreds of thousands of dengue cases are reported worldwide each year. Given the difficulty in full reporting, the actual number of human infections is probably much higher than the number reported. Dengue is usually a nonspecific febrile illness that resolves with supportive therapy but the clinical spectrum ranges from asymptomatic infection through severe hemorrhage and sudden fatal shock into expanded dengue syndrome. The pathophysiology of the severe forms of dengue may be related to sequential infection with different serotypes, variations in virus virulence, interaction of the virus with environmental and host factors, or a combination of these factors. Control of dengue at the present time is dependent on control of the principal vector mosquito, A. aegypti. Vaccine development continues, but at present the only way to avoid dengue in an area where it is endemic or epidemic is to use repellents and mosquito barriers. The movement of people to and from tropical areas makes dengue an important differential diagnosis in any patient with an acute illness and history of recent travel to tropical areas. Recently, the disease is clearly documented to have re-emerged on this subcontinent but, with an expanded spectrum of clinical manifestations and complications, as observed in clinical experience. There are also regional differences in the clinical spectrum observed within India, probably due to antigenic variation of the organism. Therefore, it is important to study the demographical factors contributing to the disease occurrence, clinical presentations including their variability, laboratory details, treatment particulars and outcomes of the dengue fever in this region. This will improve the knowledge on this expanding clinical syndrome in our region.

Scope of the project:
This is intended to develop preliminary Indian current data on the various aspects of course of illness of dengue fever. There seems to have a good scope to optimize and improve the existing practice in the current empirical antibiotic era. The atypical manifestations will be described and predictors of mortality will be identified. Largely, the database of dengue will be created for this region and it will help in planning many future studies.
 
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