| CTRI Number |
CTRI/2020/05/025443 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
28/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
The rational use of antibiotics |
|
Scientific Title of Study
|
The rational use of antibiotics in tertiary care hospitals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janki Patel |
| Designation |
Lecturer |
| Affiliation |
KBIPER |
| Address |
, Dept. Of Pharmacology and Pharmacy Practice, KBIPER , Gandhinagar
Gandhinagar
GUJARAT
382023
India |
| Phone |
9409592368 |
| Fax |
|
| Email |
jankipharmd26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriklp Despande |
| Designation |
Principle |
| Affiliation |
KBIPER |
| Address |
Department of pharmacology & Pharmacy Practice,Principle office, KBIPER Gh 6 Gandhinagar
Gandhinagar
GUJARAT
382023
India |
| Phone |
94277774447 |
| Fax |
|
| Email |
shrikalp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janki Patel |
| Designation |
student(phd) |
| Affiliation |
KBIPER |
| Address |
Department Of pharmacology & Pharmacy Practice, Pharmacy Practice Laboratory, KBIPER Gh 6 Gandhinagar
Gandhinagar
GUJARAT
382023
India |
| Phone |
9409592368 |
| Fax |
|
| Email |
jankipharmd26@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Janki Patel |
| Address |
KBIPER Gandhinagar |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KBIPER |
KBIPER Gandhinagar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Janki Patel |
Lions Hospital |
internal medicine ward , jail road
Mahesana
GUJARAT |
251130
jankipharmd26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBIPER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K90-K95||Other diseases of the digestive system, (2) ICD-10 Condition: A15||Respiratory tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
prescribing pattern and usage of antibiotic |
drug use evaluation is done and according to that active and passive intervention will be provided to physician at hospital site
Dose and duration of antibiotics will be compare with standard guidelines
eg. Azithromycin ( Oral)250 mg, 500 mg
Cetriaxone( IV/ Oral) 1000 mg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Hospitalized patients on antibiotics in internal medicine . (Male and female)
Hospitalization period more than 24 hours.
Age above 18 years
|
|
| ExclusionCriteria |
| Details |
Patients who are unconscious or semi conscious.
Pregnant or lactating women.
 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved Drug Use Pattern
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved knowledge regarding infectious disease |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
31/05/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial will be conducted to check prescribing pattern of antibiotic by enrolling patients who have diagnosed with infectious disease condition. Improve prescribing pattern and rational use of antibiotics. |