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CTRI Number  CTRI/2024/04/066497 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective, Observational Study 
Study Design  Single Arm Study 
Public Title of Study   A Observational Study to understand the Effectiveness and Tolerability of Azithromycin on Patients with Upper Respiratory Tract Infection. 
Scientific Title of Study   Assessment of CliniCal Efficacy and Safety of Azithromycin in PharyngiTis ACCEPT 
Trial Acronym  ACCEPT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dinesh Patil MBBS MD 
Designation  General Manager, Medical Services 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Department of Medical Services, 2nd floor, Prime Corporate Park, Alembic Pharmaceuticals Ltd, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E)

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  9823953957  
Fax    
Email  dinesh.patil@alembic.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Patil MBBS MD 
Designation  General Manager, Medical Services 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Department of Medical Services, 2nd floor, Prime Corporate Park, Alembic Pharmaceuticals Ltd, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E)

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  9823953957  
Fax    
Email  dinesh.patil@alembic.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh Patil MBBS MD 
Designation  General Manager, Medical Services 
Affiliation  Alembic Pharmaceuticals Limited 
Address  Department of Medical Services, 2nd floor, Prime Corporate Park, Alembic Pharmaceuticals Ltd, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E).

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  9823953957  
Fax    
Email  dinesh.patil@alembic.co.in  
 
Source of Monetary or Material Support  
Alembic Pharmaceuticals Ltd. Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai 400099  
 
Primary Sponsor  
Name  Alembic Pharmaceuticals Ltd. 
Address  Alembic Pharmaceuticals Ltd. (2nd floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai - 400 099 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dinesh Patil MBBS MD  Alembic Pharmaceuticals Ltd.  Alembic Pharmaceuticals Ltd.2nd floor, Prime CorporatePark, Behind ITC GrandMaratha Sheraton, SaharRoad, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA 		 9823953957

dinesh.patil@alembic.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira IVF Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J029||Acute pharyngitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Adult patients aged more than or equal to 18 years of either gender

2. Patients who had received oral Azithromycin for the management of pharyngitis in the past. 
 
ExclusionCriteria 
Details  Patients those who were not suitable to receive Azithromycin tablet in management of Pharyngitis as per the local prescription data 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of Patient achieving clinical cure (Clinical cure is defined as complete resolution of clinical sign & symptoms of pharyngitis)  From baseline till 5th day after treatment initiation 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients having treatment related side-effects on day 3 and day 5  Day 3 and Day 5 after treatment initiation  
 
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)   15/05/2024 
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="3"
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   This  is a Retrospective, Observational, Real world evidence, data retrieval study planned with an objective “To evaluate the efficacy and safety of Azithromycin in patients who had received it in the past for the treatment of pharyngitis”. For evaluating efficacy, assessment of the severity and course of the disease were done by using clinical findings and symptoms of the pharyngitis. Severity of the disease will be classified into three groups:mild, moderate and severe. The data retrieval will be done from the ENT specialists using medical records of the patients.
For safety evaluation, the reported adverse events which resulted from concurrent illnesses, reactions to concurrent medications were analysed through retrieved medical record form.
 
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