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CTRI Number  CTRI/2024/06/069427 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of Effectiveness And Safety Of Clarithromycin In Upper Respiratory Tract Infection 
Scientific Title of Study   A Multicentre, Prospective Post-Marketing Observational Study To Evaluate The Effectiveness And Safety Of Clarithromycin 500 Mg ER In Upper Respiratory Tract Infection 
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 Samir Bhargava 
Designation  Principal Investigator  
Affiliation  Bhargava Nursing Home 
Address  Bhargava Nursing Home, Gopal Bhuvan, 32, 1st Floor, Near Poddar School, Tagore Rd, Santacruz West, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400054
India 
Phone    
Fax    
Email  bhargavanursinghome@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kartik Peethambran 
Designation  Director Medical Affairs 
Affiliation  Abbott Healthcare Private Limited 
Address  Abbott Healthcare Private Limited Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E), Mumbai, MAHARASHTRA

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone  9920072700  
Fax    
Email  kartik.peethambaran@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Associate Director Clinical Development & Operation 
Affiliation  Abbott Healthcare Private Limited 
Address  Abbott Healthcare Private Limited Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E), Mumbai, MAHARASHTRA

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone  8657552543  
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Private Limited Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051, Indi 
 
Primary Sponsor  
Name  Abbott Healthcare Private Limited 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samir Bhargava  Bhargava Nursing Home  Gopal Bhuvan, 32, 1st Floor, Near Poddar School, Tagore Rd, Santacruz West, Mumbai, Maharashtra 400054
Mumbai (Suburban)
MAHARASHTRA 		 9820055743

bhargavanursinghome@gmail.com 
DR ILAM BARATHI  IGENT ENT Daycare Centre  1st floor, Jai Vee Builders, 57, 4th Main Rd, NCBS Colony, Nanganallur
Chennai
TAMIL NADU 		 9884076599

drbarathi54@gmail.com 
Dr Digvijay Singh Rawat  Jawaharlal Nehru Medical College  Kala Bagh, Ajmer - 305001, Rajasthan, India
Ajmer
RAJASTHAN 		 7737258659

Drdigvijaysingh231@gmail.com 
Dr MB Bharathi  JSS Hospital  M G Road, Mysore - 570004 (Near Agrahara Circle, Opposite Chamundeshwari Temple)
Mysore
KARNATAKA 		 9448275687

mbbharathi@jssuni.edu.in 
Dr Dhrubo Roy  Manipal Hospital (AMRI, mukundapur)   230, Barakhola Lane, Purba Jadavpur, Landmark: Behind Metro Cash & Carry, Kolkata 700099
Kolkata
WEST BENGAL 		 9831214266

dhruboroy1970@gmail.com 
Dr Mubarak Khan  Sushrut ENT Hospital and Dr Khans Research center  Talegaon Chakan Road, Talegaon Dabhade, opposite Parulekar High school, Pune, Maharashtra 410507
Pune
MAHARASHTRA 		 9822646207

ent.khan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
AMRI Hospitals Ethics committee   Approved 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College  Approved 
Institutional ethics committee, JSS Medical College  Approved 
RIPON INDEPENDENT ETHICS COMMITTEE  Approved 
Royal Pune Independent Ethics Committee  Approved 
Suraksha – Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clarithromycin 500 mg ER  In this PMS patients seeking treatment for URTI will continue receiving clarithromycin 500 mg ER tablets once daily for seven days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Male and female patients 18 to 65 years of age
2 Newly diagnosed patients with onset of symptoms in previous 7 days with acute URTI (acute bacterial sinusitis, acute pharyngotonsillitis or acute otitis media) in the designated clinics as part of routine clinical care
3 Patients prescribed to start clarithromycin 500 mg ER tablets once daily, as part of routine clinical practice
4 Patients willing and able to sign a patient authorisation form (PAF) prior to study participation 
 
ExclusionCriteria 
Details  • Patients who had been diagnosed and treated for an acute infection within the previous 28 days of study enrolment.
• Patients who may require hospitalization or ventilator support for the present complaints.
• Patients with history of clarithromycin or other antibiotic use in the preceding 1 month of study enrolment.
• Patients diagnosed with LRTI as per Investigator discretion.
• Hypersensitivity to macrolides.
• Patients on concomitant medication like steroids or other antibiotics.
• Patients on any other contraindicated medication based on approved prescribing information.
• Patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including anti.
• Pregnant or lactating women.
• Patients with any other conditions or diseases that Investigator/ HCP considers as ineligible to enroll in the study based on approved prescribing information. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of clarithromycin 500 mg ER in adult patients with acute bacterial upper respiratory tract infections (otitis media, sinusitis and pharyngotonsillitis) by evaluating percentage of patients termed cured/ improved/ failure.  Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effectiveness of clarithromycin 500 mg ER in adult patients with acute bacterial upper respiratory tract infections (otitis media, sinusitis and pharyngotonsillitis) by evaluating the percentage change in clinical symptoms scores.  Day 7 
 
Target Sample Size   Total Sample Size="237"
Sample Size from India="237" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="237" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 02/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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, Multicenter, Open-Label, Post-Marketing Observational Study To Evaluate The Effectiveness And Safety Of Clarithromycin 500 Mg ER In Upper Respiratory Tract Infection approximately on 237 patients from approximately 6 clinical sites. There are two Onsite visits and one telephonic visit on 5th day after second visit in the study and study duration is of 7 days +/- 2 (Onsite visit) and 5th day after second visit (Telephonic visit) day window period.
 
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