CTRI Number |
CTRI/2018/09/015666 [Registered on: 10/09/2018] Trial Registered Prospectively |
Last Modified On: |
12/08/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Longitudinal |
Study Design |
Other |
Public Title of Study
|
The disease profile of enteric fever in North India |
Scientific Title of Study
|
To study the disease profile of enteric fever in patients at AIIMS, Rishikesh with focus on the demographical, clinical, laboratory, treatment, and outcome variables including antibiotic susceptibility pattern |
Trial Acronym |
DPEF-North-India Study |
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 |
Dept of Medicine, Fifth 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 |
Dept of Medicine, Fifth floor, College block, AIIMS, Rishikesh
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 |
Dept of Medicine, Fifth floor, College block, AIIMS, Rishikesh
UTTARANCHAL 249203 India |
Phone |
9868999488 |
Fax |
|
Email |
prasan.med@aiimsrishikesh.edu.in |
|
Source of Monetary or Material Support
|
Research cell,
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 |
PRASAN KUMAR PANDA |
AIIMS Rishikesh |
Dept of Medicine, Fifth Floor, College block 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
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: A30-A49||Other bacterial diseases, (2) ICD-10 Condition: A010||Typhoid fever, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
1.Blood and/or stool and/or bone marrow and/or other appropriate clinical specimens’ culture positive S. typhi or S. paratyphi
2.Clinical diagnosis of enteric fever
|
|
ExclusionCriteria |
Details |
No exclusion criteria except where consent could not be obtained |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
1.To study the demographical, clinical, laboratory, treatment, and outcome variables of confirmed enteric fever patients at AIIMS
2.To study the antibiotic susceptibility pattern of enteric fever at AIIMS |
Each sample @ 0, 3 days, 7days, Discharge, and One, two , and three months follow up |
|
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)
|
19/09/2018 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Justification for study: Studies worldwide suggest that infectious disease is a major health problem, especially in developing countries like India. Various studies have shown the changing patterns in the course of enteric fever considering the antibiotic resistance profile. However, studies on various contributing factors during the same course of the disease starting from the aetiology to outcome in India are few. The present trends of the enteropathogens and their susceptibility to various antibiotics are essential to formulate the local guideline for the management of the disease while awaiting the culture sensitivity. The aim of the present study is to record the demographical factors contributing the disease occurrence, clinical presentations including their variability, laboratory details, treatment particulars, and outcome for enteric fever. The distribution of bacterial strains isolated from complicated and uncomplicated enteric fevers and their resistance pattern against commonly used antibiotics at our setting will also be studied. | Scope of the Project:- There seems to have a good scope to optimize and improve the existing practice in the current empirical antibiotic selection as well as antibiotic selection based on antibiogram . This will reduce the cost burden due to the enteric fever, reduce the emergence of resistance due to irrational antibiotic use, and minimize morbidity due to the disease. This is also intended to develop a preliminary Indian current data on the various aspects of course of illness of enteric fever. The positive sample will also be stored for future molecular analysis if required. | |