| CTRI Number |
CTRI/2023/06/053998 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check relationship between diabetes mellitus and urinary tract infection , associated complication in hospital admitted patients |
|
Scientific Title of Study
|
A Study on the clinical profile of urinary tract infection in patients of diabetes mellitus in a tertiary care hospital in south india |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagar sindhu |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college and hospital, manipal |
| Address |
Department of General medicine,kasturba hospital ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8818088499 |
| Fax |
|
| Email |
sagarsindhu25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudeva acharya |
| Designation |
Head of unit, Professor |
| Affiliation |
Kasturba medical college and hospital, manipal |
| Address |
Department of General medicine,kasturba hospital ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197597008 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudeva acharya |
| Designation |
Head of unit, Professor |
| Affiliation |
Kasturba medical college and hospital, manipal |
| Address |
Department of General medicine,kasturba hospital ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197597008 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
|
Source of Monetary or Material Support
|
| 2 nd floor ,Department of general medicine,Kasturba hospital, manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Second floor Department of general medicine KMC manipal |
| 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 |
| Sagar sindhu |
Kasturba hospital |
2nd floor department of general medicine Kasturba hospital,madhav nagar, manipal
Udupi
KARNATAKA |
8818088499
sagarsindhu25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-2[student research],kasturba medical college and kasturba hospital,manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, (2) ICD-10 Condition: N30-N39||Other diseases of the urinary system, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient with diabetes mellitus [ known cases on treatment as well as recently detected cases].
patient with diabetes mellitus having symptomatic or asymptomatic bacteriuria [ positive urine culture].
|
|
| ExclusionCriteria |
| Details |
Patient with prolonged catheterization
Gestational diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Finding the most common signs, symptoms and risk factors associated with urinary tract infection in diabetes mellitus
|
20 months data compilation and analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Finding the complications of UTI in Diabetes mellitus |
Baseline, 17 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Title of the project : A STUDY ON THE CLINICAL PROFILE OF URINARY TRACT INFECTION IN PATIENTS OF DIABETES MELLITUS IN A TERTIARY CARE HOSPITAL IN SOUTH INDIA 2. Type of Study: Observational, Descriptive, Cross sectional, Hospital based study 3. Aims & objectives : AIM-To study the clinical profile of URINARY TRACT INFECTION in DIABETES MELLITUS OBJECTIVES- 1] To study the clinical profile and risk factors of patients with UTI in DM 2] To study the organism causing UTI, its antibiotic susceptibility and complications caused with respect to gender. 3] To study the incidence and associated risk factors of Recurrent UTI |