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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
Intervention / Comparator Agent
|
|
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 |
0 |
|
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. |