| CTRI Number |
CTRI/2020/02/023601 [Registered on: 26/02/2020] 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 Swine Flu (H1N1) in AIIMS Rishikesh (DPSF study) |
|
Scientific Title of Study
|
To study the Disease Profile of Swine Flu (H1N1) 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 |
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
Public Query
|
| Name |
PRASAN KUMAR PANDA |
| Designation |
ASST. 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: J09X||Influenza due to identified novelinfluenza A virus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All serological positive swine flu (H1N1) cases (both children and adult) for next two years
2. Clinical diagnosis of swine flu (H1N1)
3. Patient medical records available from November 2018 to present time for retrospective cohort
|
|
| ExclusionCriteria |
| Details |
1. Positive cases who have been admitted in other than medicine/pediatric dept where medicine/pediatric 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 Swine flu (H1N1) patients at AIIMS
2. To determine Himalayan and sub-Himalayan variation of same cohort
3. To determine the predictors of morbidity and mortality of same cohort
|
The total study duration will be 2 years |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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. Guidelines on Categorization of Influenza A H1N1 Cases during Screening for Home Isolation, Testing Treatment, and Hospitalization. Available from: http://www.mohfw. nic.in/WriteReadData/l892s/804456402Categorisation.pdf, accessed on August 20, 2019.
2. Khanna M, Kumar P, Choudhary K, Kumar B. Emerging influenza virus: a serious global threat. J Biosci. 2008;33:475–82.
3. Malhotra B, Singh R, Sharma P, Meena D, Gupta J, Atreya A, Meena B R. Epidemiological & clinical profile of influenza A (H1N1) 2009 virus infections during 2015 epidemic in Rajasthan. Indian J Med Res 2016;144:918-23.
4. Vijaydeep S, Vineet G, Vipin K. Clinical-epidemiological profile of influenza A H1N1 cases at a Tertiary Care Institute of India. Indian J Community Med. 2012;37(4):232–5
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Justification for study: Influenza virus is a common human pathogen that has caused serious respiratory illness and death over the past century. Swine flu is an infection caused by any one of several types of swine influenza viruses, amongst which H1N1 influenza virus is the most common virus causing swine flu in humans. Following its emergence in March 2009 in Mexico, the H1N1 virus spread rapidly throughout the world. The WHO declared H1N1 as a pandemic and the disease started in India in same year. This infection spreads so easily and has a high mortality and morbidity rate, therefore it has become an important public health problem and has potential to lead to frequent pandemics. Therefore, it is important to study the demographical factors contributing the disease occurrence, clinical presentations including their variability, laboratory details, treatment particulars, and outcomes of the swine flu (H1N1) 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 a North-Indian current data on the various aspects of course of illness of swine flu (H1N1) in this region of India. There seems to have a good scope to optimize and improve the existing practice in the current empirical antibiotic era for any febrile illness. |