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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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  
Outcome  TimePoints 
NA  NA 
 
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.

 
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