| CTRI Number |
CTRI/2020/03/024213 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
18/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Drug Utilisation Evaluation of antibiotics in Multidrug resistant Urinary Tract Infection. |
|
Scientific Title of Study
|
Drug Utilisation Evaluation of antibiotics and the prevalence of multidrug resistant Urinary Tract Infection 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 |
Asthaa Malhotra |
| Designation |
PharmD intern |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9740216590 |
| Fax |
|
| Email |
asthaarmalhotra@gmail.con |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kanav Khera |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7889271828 |
| Fax |
|
| Email |
Kanav.khera@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Asthaa Malhotra |
| Designation |
PharmD intern |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9740216590 |
| Fax |
|
| Email |
asthaarmalhotra@gmail.con |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Asthaa Malhotra |
| Address |
Department of Pharmacy Practice, Room no. #1, Kasturba Hospital, Manipal, 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Asthaa Mahotra |
Kasturba Hospital |
Department of Pharmacy Practice, Kasturba Hospital, Manipal, Karnataka, 576104 Udupi KARNATAKA |
9740216590
asthaarmalhotra@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: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with final diagnosis of UTI resistant to three or more than three classes of antibiotics. |
|
| ExclusionCriteria |
| Details |
Patients file with incomplete data |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Drug Utilisation Evaluation of multi drug resistant Urinary Tract Infection. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Most common resistant bacteria
Most common resistant drug |
1 week |
|
|
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)
|
25/03/2020 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Urinary tract infections are the second most common infections that drive the use of antibiotics, an estimate of 150 million UTIs occur every year globally, this has led to increasing use of empirical therapy and bacterial resistance which in turn cascades into increased treatment failures. Various studies show clear increase in antibiotic resistance among uropathogens. Recurrent urinary tract infections (UTI) are common among young healthy women even though they generally have anatomically and physiologically normal urinary tracts. Hence, the surveillance of antibiotic susceptibility pattern is essential for the appropriate treatment and reduced remission of infection. There is a lack of literature on the prevalence of MDR UTI in South India therefore, this study is carried out to depict the treatment pattern and prevalence of MDR UTI in a 2000 bedded hospital in Karnataka to improve the quality of treatment of patients. |