| CTRI Number |
CTRI/2022/09/045611 [Registered on: 16/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Drug-Drug Interactions and Prescription Appropriateness in COVID-19 ICU Patients |
|
Scientific Title of Study
|
"Drug-Drug Interactions and Prescription Appropriateness in COVID-19 ICU Patients in a Tertiary Care Hospital†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suraj B |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Room Number 203, 2nd Floor
ESIC Medical College and Hospital, Bihta, Patna
Bihar
Patna
BIHAR
801103
India |
| Phone |
8861083454 |
| Fax |
|
| Email |
drsurajpanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suraj B |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Room 203, 2nd Floor
Department of Pharmacology
ESIC Medical College and Hospital, Bihta, Patna
Bihar
Patna
BIHAR
801103
India |
| Phone |
8861083454 |
| Fax |
|
| Email |
drsurajpanchal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suraj B |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Room Number 203, 2nd Floor
Dept of Pharmacology
ESIC Medical College and Hospital, Bihta, Patna
Bihar
Patna
BIHAR
801103
India |
| Phone |
8861083454 |
| Fax |
|
| Email |
drsurajpanchal@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Gulbarga, Karnataka-585106 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
ESIC Medical College and Hospital, Gulbarga, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shvesh Moza |
ESIC Medical College and Hospital |
Room no 521, Fifth Floor, Department of Pharmacology
Gulbarga
KARNATAKA |
8826259919
shveshmoza@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, ESIC Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U071||COVID 19 virus identified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Case record of all adult patients with proven diagnosis of SARS-CoV-2 infection (a throat swab positive for viral nucleic acid) admitted to the COVID-19 ICU during the study period and treated with at least two drugs will be considered. |
|
| ExclusionCriteria |
| Details |
Patients transferred to other wards from ICU or discharged/death within 24hr of admission will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the frequency and severity of potential DDIs in COVID-19 ICU patients |
March to July 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate PIMs in the subset of patients aged more than or equal to 65 years |
March to July 2021 |
|
|
Target Sample Size
|
Total Sample Size="191"
Sample Size from India="191"
Final Enrollment numbers achieved (Total)= "191"
Final Enrollment numbers achieved (India)="191" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/09/2022 |
| Date of Study Completion (India) |
08/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the investigational therapies and in addition to specific therapy for COVID-19 patients; the overall pharmacological burden may pose an extremely high risk of potential drug drug interactons (pDDIs), prescription inappropriate medications (PIMs) and drug specific adverse events. Therefore an optimized and safer prescription practice in multiple co-morbid conditions and older individuals is often a difficult task.
However, to address these issues, various computerized prescriptions support systems have been developed and one such is INTERCheck® which stores information on explicit criteria for PIMs, anticholinergic load, potential DDIs, dose adjustment in cases of renal impairment and modality for drug withdrawals (dose tapering). With limited data in Indian context which addresses the burden of DDIs and PIMs in COVID-19 ICU patients, the present study aims to evaluate the pattern of DDIs, pharmacological burden and PIMs upon admission and during hospitalization. |