| CTRI Number |
CTRI/2024/11/076526 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of antibiotic utilization in diabetic patients with infection |
|
Scientific Title of Study
|
Assessment of antibiotic utilization in diabetic patients with infection: a prospective longitudinal study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lloyd Blannie Barnes |
| Designation |
Student |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of pharmacy practice, Manipal College Of Pharmaceutical Sciences, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8884957241 |
| Fax |
|
| Email |
lloydbarnes13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammed Salim KT |
| Designation |
Assistant professor |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of pharmacy practice, Manipal College Of Pharmaceutical Sciences, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9656798071 |
| Fax |
|
| Email |
salim.kt@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammed Salim KT |
| Designation |
Assistant professor |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of pharmacy practice, Manipal College Of Pharmaceutical Sciences, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9656798071 |
| Fax |
|
| Email |
salim.kt@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Infrastructural support- Kasturba Hospital, Madhav Nagar, Manipal, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Muralidhar Varma D |
Kasturba Hospital Manipal |
Room number 3 Department of Infectious Diseases KMC Manipal
Udupi
KARNATAKA |
9845069639
muralidhar.varma@manipal.edu |
|
|
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: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders and above 18 years of age with known case of diabetes with presence of culture positive bacterial infections are included. |
|
| ExclusionCriteria |
| Details |
Lactating or pregnant patients are excluded. Terminally ill and psychiatric patients are excluded. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| ADRs, drug interactions, appropriateness of antibiotic treatment and need for deescalation of antibiotic therapy |
At baseline and everyday until the date of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="366"
Sample Size from India="366"
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)
|
11/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A Prospective study will be conducted at the Department of Infectious Diseases that will include minimum of 366 patients with culture positive infections and diabetes. Literature review will be conducted followed by development of Case Report Form to collect relevant clinical data of the patients. The appropriateness of the prescriptions of antibiotics will be assessed and will also look for ADRs and conduct Causality and Severity assessment. Drug-Drug interactions will be identified. There will be base line data collection and follow up. Need of de-escalation of antibiotic administration will be evaluated as per guidelines. |