| CTRI Number |
CTRI/2020/01/022985 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
14/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate clinical and laboratory characteristics of patients admitted with typhoid fever |
|
Scientific Title of Study
|
CLINICAL AND LABORATORY PROFILE OF ENTERIC FEVER |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RANITHA GOPI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA HOSPITAL MANIPAL |
| Address |
Room no 2,Department office, Department of General Medicine,2nd floor ,OPD Building,Kasturba Hospital Manipal,Manipal,Udupi
Room no 2,Department office, Department of General Medicine,2nd floor, OPD Building,Kasturba Hospital Manipal
Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7022884320 |
| Fax |
|
| Email |
ranithagra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAVIRAJA ACHARYA |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
KASTURBA HOSPITAL MANIPAL |
| Address |
Room No 2,Department office, Department of General Medicine, 2nd floor, OPD building,Kasturba Hospital Manipal, Manipal, Udupi
Room No 2,Department office, Department of General Medicine, 2nd floor, OPD building,Kasturba Hospital Manipal, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9141371000 |
| Fax |
|
| Email |
ravi.katte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RANITHA GOPI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA HOSPITAL MANIPAL |
| Address |
Room no 2,Department Office, Department of General Medicine, 2nd floor, OPD building, Kasturba Hospital Manipal,Manipal,Udupi
Room no 2,Department Office, Department of General Medicine, 2nd floor, OPD building, Kasturba Hospital Manipal,Manipal,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7022884320 |
| Fax |
|
| Email |
ranithagra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medicine 6 reasearch fund-Kasturba Medical College Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Manipal University, Manipal 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ranitha Gopi |
Kasturba Hospital Manipal |
Room no 2, Department Office, Department of General Medicine, 2nd floor,OPD building
Udupi
KARNATAKA |
7022884320
ranithagra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A01||Typhoid and paratyphoid fevers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
nil- study is an observational cross sectional study- clinical and laboratory profile of enteric fever |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age of both sexes who can give informed consent with Widal titres more than 1:160 and or blood culture positive cases |
|
| ExclusionCriteria |
| Details |
Age less than 18 years or patients who are not able to give informed consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
A detailed clinical profile of all enteric fever patients admitted to Kasturba Hospital Manipal can be obtained
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The sensitivity of PCR in detecting Salmonella antigen in patients can be assessed
The sensitivity of Widal vs PCR can be assessed in diagnosis of Enteric fever
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="127"
Sample Size from India="127"
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)
|
31/01/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an observational cross sectional study - A clinical and laboratory profile of all patients admitted with enteric fever during the study period to Kasturba Hospital Manipal .In addition PCR screening for Salmonella typhi antigen will be done in all blood culture positive cases. Outcomes-descriptive study. Sensitivity of PCR detection can be assessed . |