| CTRI Number |
CTRI/2024/07/069857 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Which Test Is best for finding Urinary Tract Infection a basic comparison |
|
Scientific Title of Study
|
Compare the efficiency of various screening tests performed for the diagnosis of urinary tract infection (UTI) in patients visiting AVBRH. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janhvi Tudamwar |
| Designation |
Post Graduation |
| Affiliation |
Datta Meghe Institution of Higher Education And Research |
| Address |
Microbiology Department second floor JNMC Building Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7773976285 |
| Fax |
|
| Email |
jtudamwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praful Patil |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Microbiology Department JNMC Building Second Floor Sawangi,Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284544743 |
| Fax |
|
| Email |
prafulp036@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janhvi Tudamwar |
| Designation |
Post Graduation |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Microbiology Department JNMC Building 2nd floor sawangi,Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7773976285 |
| Fax |
|
| Email |
jtudamwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi,meghe 442001,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi(Meghe),Wardha, Maharashtra,India,442001 |
| 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 |
| DrJanhvi Tudamwar |
Datta Meghe Institute of Higher Education and Research |
Microbiology Department 2nd floor JNMC building
Wardha
MAHARASHTRA |
7773976285
jtudamar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, (2) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient who has symptoms of or susceptibility of uti and age between 10-65 years |
|
| ExclusionCriteria |
| Details |
only those patient who are bellow 10 years |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| catalase test, gram stain, griess nitrate and triphenyl tetrazolium chloride tests will be screened for Uriary tract infection |
Assessment will be done in 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="381"
Sample Size from India="381"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Urinary tract infections (UTIs) are a common bacterial ailment with significant healthcare implications. This protocol aims to assess the efficacy of various screening tests for UTI diagnosis among patients at AVBRH. Standard diagnostic methods, such as microscopic urine examination and bacterial culture, have limitations in terms of practicality and cost-effectiveness. As such, alternative screening tests, including gram staining, Griess nitrite test, and triphenyl tetrazolium chloride (TTC) test, are being investigated for their utility in UTI management. Specifically, the study seeks to compare the performance of these tests and evaluate their applicability in clinical settings. The findings from this research could contribute to improved diagnostic accuracy and streamlined patient care for UTIs, ultimately benefiting both healthcare providers and patients alike. |