| CTRI Number |
CTRI/2023/05/053245 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prescriptions in the PICU |
|
Scientific Title of Study
|
Antibiotic prescription patterns in the PICU
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asma Javed |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of pediatrics, woman and child block, KMC Manipal
Bangalore
KARNATAKA
576104
India |
| Phone |
9890893697 |
| Fax |
|
| Email |
dr.asmajaved20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneel C Mundkur |
| Designation |
Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of pediatrics, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845150802 |
| Fax |
|
| Email |
Suneel_cm@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneel C Mundkur |
| Designation |
Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of pediatrics, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845150802 |
| Fax |
|
| Email |
Suneel_cm@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics,
KMC, Manipal |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of pediatrics, KMC Manipal |
| 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 |
| Dr Asma Javed |
PICU, KMC Manipal |
PICU, 2nd floor, department of pediatrics, Kasturba hospital, KMC manipal
Udupi
KARNATAKA |
9890893697
dr.asmajaved20@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-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z163||Resistance to other antimicrobialdrugs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted in the PICU |
|
| ExclusionCriteria |
| Details |
Patients/ parents denying consent
Pediatric oncology patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY INDICATIONS FOR PRESCRIPTIONS IN THE PICU |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study antibiotic review with respect to dose modifications/ change in antibiotic/ change in route of administration during the course of treatment in the PICU |
3 days |
| To study factors determining the decision to stop antibiotics in patients admitted in the PICU |
5 days |
|
|
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)
|
10/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STEP 1: IEC approval will be taken prior to the study. After the approval of the ethics committee, the study will commence.STEP 2: Informed consent will be obtained from the parents of the study participants.
STEP 3: Data will be collected in the form of history as well as clinical examination, investigations will be recorded according to the format of the proforma designed for the study.
STEP 4: Each patient will be categorised into one out of four categories based on the antibiotic use in the patient. 1. Antibiotic indicated + prescribed 2. Antibiotic indicated + not prescribed 3. Antibiotic not indicated + prescribed 4. Antibiotic not indicated + not prescribed The focus remains on categories 1 and 4, to study the common indications of antibiotic use at our PICU. We don not expect many patients to fall under categories 2 and 3 due to our vigilant patient care. However, it is important to include them in case of special circumstances.
STEP 5: Once an antibiotic has been prescribed, relevant details such as the dose, route, duration of therapy will be documented.
STEP 6: Further the plan on review of antibiotic therapy will be followed. On review, the change in plan of antibiotic use will be categorised as one of the following: Change the dose, Change the route, Stop antibiotic, Continue same treatment. |