| CTRI Number |
CTRI/2024/03/064343 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Descriptive Study of the Prescribing Pattern of Drugs in Chronic Suppurative Otitis Media and Impact of Disease on Health-Related Quality of Life in Patients Attending ENT OPD at SMS HOSPITAL, Jaipur |
|
Scientific Title of Study
|
A Descriptive Study of the Prescribing Pattern of Drugs in Chronic Suppurative Otitis Media and Impact of Disease on Health-Related Quality of Life in Patients Attending Otorhinolaryngology Out Patient Department at Sawai Man Singh Hospital, Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR. Prateek Saini |
| Designation |
M.D pharmacology resident |
| Affiliation |
department of pharmacology, SMS Medical College |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004 India Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004 India Jaipur RAJASTHAN 302004 India |
| Phone |
9785908055 |
| Fax |
|
| Email |
prateeksaini798@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR. RUPA KAPADIA |
| Designation |
Senior Professor |
| Affiliation |
Sawai man Singh medical College and hospital Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004, India Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004, India Jaipur RAJASTHAN 302004 India |
| Phone |
9929871911 |
| Fax |
|
| Email |
drrupakapadia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR. Prateek Saini |
| Designation |
M.D pharmacology resident |
| Affiliation |
Sawai man Singh medical College and hospital Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004, India Department of Pharmacology, SMS Medical College, Jaipur Rajasthan 302004 India Jaipur RAJASTHAN 302004 India |
| Phone |
9785908055 |
| Fax |
|
| Email |
prateeksaini798@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of ear nose throat second floor building sawai man singh medical college jaipur |
|
|
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 PRATEEK SAINI |
ear nose throat out patient clinic DHANVANTARI BHAWAN SMS HOSPITAL JAIPUR |
Sawai man Singh road SMS Hospital Jaipur Rajasthan Jaipur RAJASTHAN |
9785908055
PRATEEKSAINI798@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, S.M.S. Medical College And Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H664||Suppurative otitis media, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with CSOM with or without active recurrent otorrhea and visible tympanic membrane perforation, visiting OPD of Otorhinolaryngology department.
Adult patient of either sex. Patients willing to give written informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with non-infective conditions, E.g., Malignancy and Road traffic accidents.
2. Patients with aural discharge with any cause other than CSOM. E.g., foreign body, furunculosis, and post-operative patients of CSOM.
3. Patients with co-morbid conditions like cancer, HIV, hepatitis.
4. Patients are part of any other study.
5. Non corporative patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Active aural discharge |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Average number of drugs per encounter
2. Percentage of drugs prescribed with the generic name
3. Percentage of encounters with antimicrobials prescribed
4. Percentage of encounters with injections prescribed
5. Percentage of drugs prescribed from Essential Drugs List (EDL)
6. Proportion of drugs prescribed rationality as per the Standard Treatment Guidelines (6th Edition)
7. Mean QOL scores based on the COMOT-15 Questionnaire in the enrolled patients
8. Proportion of cases developing Adverse drug reactions (ADRs) to the prescribed drugs
9. Describe tantimicrobial susceptibility pattern of different pathogenic bacteria
|
6 MONTH |
|
|
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)
|
29/03/2024 |
| 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="0" Months="6" 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
|
Chronic suppurative otitis media (CSOM) is a chronic infective,
inflammatory disorder of the middle ear characterized by recurrent otorrhea for
at least 2–6 weeks, through tympanic
membrane perforation.1 It causes a myriad of intermittent or
persistent symptoms across all age groups like ear discharge, hearing loss,
tinnitus, and vertigo. CSOM has emerged as one of the most common causes of
acquired hearing loss.2 It is a common condition encountered in the
Ear, Nose, and Throat (ENT) department worldwide. A systematic analysis done by
Vos et al. revealed that worldwide approximately 4.4% of the human population
is affected by chronic suppurative otitis media (CSOM).3 The World
Health Organization (WHO) estimates CSOM incidence between 65-330 million with,
50% of individuals with hearing impairment.3
CSOM can lead to significant morbidities, including hearing loss,
recurrent infections, and potential complications such as mastoiditis, cholesteatoma,
and intracranial infections.4 The management of CSOM typically
involves a combination of medical and surgical interventions. Antibiotics play
an important role in controlling infection and promoting healing of the middle
ear infection. However, the irrational and inappropriate use of antibiotics can
contribute to the emergence and spread of antimicrobial drug resistance, which
is a global public health concern.5
WHO defined Drug
Utilization Research as, “Studies of the marketing, distribution, prescription,
and use of drugs in a society, with special emphasis on the resulting medical,
social, and economic consequencesâ€. This study aims to critically analyse the
prescriptions issued at the ENT outpatient
department of the hospital. This study is to find out areas that need
improvement in the overall interest of the patient and the healthcare system.6
Drug utilization
monitoring can be used to assess the Rational use of drug therapy, outcome of
treatment, and quality of life care. CSOM can also a produce significant impact
on the quality of life of the affected individuals. In many cases, CSOM
patients suffer from many complications like hearing loss, emotional impact,
impact on day-to-day activities, social impact, and its impact on sleep. The
present study was planned to evaluate the prescribing pattern of
drugs along with the study of the impact of disease on health-related quality of
life (QOL) in patients suffering from CSOM.7
WHO defined Rational
use of drugs as “A state in which medications are received by patients
appropriately according to their clinical needs and individual requirements,
for an adequate period at the lowest costâ€. The various repercussions of
irrational drug use include polypharmacy, increased use of branded drugs,
increased drug cost per person, drug interactions, adverse effects, irrational
antibiotic prescribing, and antibiotic resistance and it may lead to a post-antibiotic
era, then it will be very difficult to treat even mild infections. This
justifies the need for an antibiotic policy that comprises microbiological data
and prescription auditing in any geographical area. Rational use of antimicrobial agents requires proper
clinical evaluation, judgment, and a comprehensive understanding of
microbiological and pharmacological factors, and only through the rational
prescribing practices of the clinician, the overuse and misuse of antibiotics
issues can be resolved globally.8
Due
to the irrational use of antibiotics, Antimicrobial Resistance (AMR) is also increasing
among the pathogens causing CSOM. This necessitates the evaluation of
antimicrobial drug susceptibility patterns in these patients on the basis of
culture and sensitivity.9 Antimicrobial
Stewardship is defined as “The careful and responsible management of something
entrusted to one’s careâ€. It was originally applied in the healthcare setting
as a tool for optimizing antimicrobial use, termed “Antimicrobial stewardshipâ€
(AMS). Stewardship has been applied in the context of governance of the health
sector as a whole, taking responsibility for the health and well-being of the
population and guiding health systems at the national and global levels.
AMS
principles also apply to the use of antimicrobials in the animal and
agriculture sectors, typically with an emphasis on the responsible and prudent
use of these agents. Core Elements of Outpatient Antibiotic Stewardship
provides guidance for antibiotic stewardship in outpatient settings and is
applicable to any entity interested in improving outpatient antibiotic
prescribing and use.10 |