CTRI/2025/05/086113 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On:
20/10/2025
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
A Multicentric, Prospective, Open Label, Real World Observational study
Study Design
Single Arm Study
Public Title of Study
Azithromycin in management of upper respiratory tract infections in pediatric patients
Scientific Title of Study
Clinical Evaluation of Azithromycin in Upper Respiratory Tract Infections in Pediatric Patients: A Multicentric, Prospective, Open Label, Real World Observational study (CURE URTI)
Trial Acronym
CURE URTI
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sanjay Mankar
Designation
Consultant in Paediatric Infectious diseases
Affiliation
Mankar hospital
Address
Mankar hospital, plot no 19, Swaroop society, behind Santosh hall, Sinhagad road, Pune – 411051, Maharashtra, India.
Pune
MAHARASHTRA
Alembic Pharmaceuticals Ltd,
2nd Floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton,
Sahar Road, Andheri (E), Mumbai, Maharashtra, 400099.
Mumbai 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 - 400 099, Maharashtra, India
Primary Sponsor
Name
Alembic Pharmaceuticals Ltd.
Address
2nd Floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai, Maharashtra 400099
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 24
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Tarun Anand
Anand Care Clinic
B-3/289, near Neelkanth sweets, Vivek Khand 3, Gomti Nagar, Lucknow - 226010, Uttar Pradesh, India Lucknow UTTAR PRADESH
9532653851
ravitarunanand@yahoo.in
Dr Ayathu Venkata Ravishankar
Child Health Clinic
Dhanwanthri, Old No. 18/1, New no 35, First main road, CIT colony, Mylapore, Chennai – 600004, Tamil Nadu, India Chennai TAMIL NADU
9884073497
docravish@gmail.com
Dr Ashok K Chakravarty
Children’s Clinic
A-4, Golf View Apartments., Anupam Pvr Road, Saket, Delhi – 110017, India South DELHI
8527650161
ashok7754@gmail.com
Dr Mukesh Sanklecha
Colaba Clinic
1st Floor, Sindh Chambers, 9C, near Kailash Parbhat Restaurant,
opposite Apollo pharmacy, Colaba, Mumbai - 400005, Maharashtra, India
Mumbai MAHARASHTRA
9869134900
doctormukesh@gmail.com
Dr Arunaloke Bhattacharya
Dr Arunaloke Bhattacharya Clinic
24/4, Raja Subodh Chandra Mallick Rd, Bidhanpally Jadavpur, Kolkata - 700032, West Bengal, India
Kolkata WEST BENGAL
9331042625
arunalokeb@yahoo.com
Dr Partha Sarathi Saha
Dr Partha Sarathi Saha’s Clinic
Emergency Medical Hall (Personal Chamber), Newtown, Diamond Harbour, South 24 Paraganas, west bengal, 743331, India South Twentyfour Parganas WEST BENGAL
9732408230
parthasarathisaha1957@gmail.com
Dr Prahalad Samdani
Dr Samdani’s Clinic
No. 217, Mehta House, Pandita Ramabai, Grant Road, Mumbai - 400007, Maharashtra, India
Mumbai MAHARASHTRA
9321096970
samdaniprahalad@hotmail.com
Dr Subhasis Roy
Dr Subhasis Roy Clinic
3, Block B, Block D, Bangur, Lake Town, Kolkata – 700055, West Bengal, India Kolkata WEST BENGAL
9830036761
roysubha2006@gmail.com
Dr Arun Wadhwa
Dr Wadhwas Clinic
G-10 Masjid Moth, Greater Kailash-II, New Delhi-110048, India New Delhi DELHI
9810067928
arun@drwadhwasclinic.com
Dr G Shivaraj Babu
G.J.S. Women and Child Care centre
25/2, Kamaraj Nagar, Main road, Avadi, Chennai – 6000071, Tamil Nadu, India Chennai TAMIL NADU
9962566016
shivrajbabu@yahoo.in
Dr Rekibuddin Ahmed
H M Hospital
Haridev Rd, beside Little flower School, Hatigaon, Guwahati - 781038,
Assam, India
Kamrup ASSAM
9435027550
drrekib@yahoo.com
Dr Ajay Kumar
Hope Mother and Child Care centre
5 D, AP Sen Rd, Cash, and Pay Colony, Charbagh, Lucknow - 226001., Uttar Pradesh, India
Lucknow UTTAR PRADESH
9415021546
drajaykumar196@gmail.com
Dr Nirmal Kumar Jain
IHR Guwahati (Goenka Nursing Home)
Bharalumukh, Guwahati – 781009, Assam, India
Kamrup ASSAM
8876511247
drnirmaljain1963@gmail.com
Dr Bhaskar Shenoy
Manjushri Children’s Clinic
460, 1st Cross Rd, opposite Indian Public School, I Block, Basaveshwar Nagar, Bengaluru - 560079, Karnataka, India Bangalore KARNATAKA
9845036174
bshenoy@gmail.com
Dr Sanjay Mankar
Mankar hospital
Plot no 19, Swaroop society, behind Santosh hall, Sinhagad road, Pune – 411051, Maharashtra, India. Pune MAHARASHTRA
9422078779
mankarsanjay@ymail.com
Dr Ritesh Kumar Jain
Marwari Hospital
B-3, Sati Joymati Rd, Athgaon, Guwahati – 781008, Assam, India Kamrup ASSAM
9435030717
riteshdrghy@gmail.com
Dr Tilak Raj Dangwal
Prism Children and Chest Clinic
Dilshad Garden, CSC, DDA Market, Pocket I, Opposite Red Cross Hospital, Delhi – 110095, India East DELHI
9810098958
drtilakraj@hotmail.com
Dr Amarapathi Gangadharan Karthikeyan
Sai Mother & Child health centre
Border Thottam, Padupakkam, Triplicane, Chennai-600014, Tamil Nadu, India Chennai TAMIL NADU
9840070123
paedkarthik@gmail.com
Dr Vijay Warad
Sai Netralaya and specialty clinic
Aranyeshwar park 2, near Aranyeshwar temple, ICICI bank building, Sahakar nagar, Pune-411009, Maharashtra, India.
Pune MAHARASHTRA
9822436184
drvijaypwarad@gmail.com
Dr Sanjeev Parikh
Sanjeev Parikh Children Hospital
Sagar Park, Road, Amrut Nagar, Ghatkopar West, Mumbai, Maharashtra 400086, India Mumbai (Suburban) MAHARASHTRA
ACE Independent Ethics Committee, The Children’s Clinic; Mico Layout, Stage 2, BTM Layout, Bengaluru- 560076, Karnataka, India Bangalore Karnataka
Approved
Central Independent Ethics Committee-CIEC, Dr Jitendra Deshmukh, Vaibhavi hospital, 225, Gajanan Colony, Survey No 15, Hadapsar, Pune – 411028, Maharashtra, India Pune Maharashtra
Approved
Central Independent Ethics Committee-CIEC, Dr Sanjay Mankar, Mankar hospital, plot no 19, Swaroop society, behind Santosh hall, Sinhagad road, Pune – 411051, Maharashtra, India. Pune Maharashtra
Approved
Central Independent Ethics Committee-CIEC, Dr Vijay Warad, Sai Netralaya and specialty clinic, Aranyeshwar park 2, near Aranyeshwar temple, ICICI bank building, Sahakar nagar, Pune-411009, Maharashtra, India. Pune Maharashtra
Approved
Good society for ethical research, Dr Arun Wadhwa, Dr Wadhwas Clinic, G-10 Masjid Moth, Greater Kailash-II, New Delhi-110048, India New Delhi
Approved
Good society for ethical research, Dr Ashok K Chakravarty, Children’s Clinic, A-4, Golf View Apartments., Anupam Pvr Road, Saket, Delhi – 110017, India South Delhi
Approved
Good society for ethical research,Dr Tilak Raj Dangwal, Prism Children and Chest Clinic, Dilshad Garden, CSC, DDA Market, Pocket I, Opposite Red Cross Hospital, Delhi – 110095, India East Delhi
Approved
Indira IVF Hospital Ethics Committee - Kolkata, Dr Arunaloke Bhattacharya, Dr Arunaloke Bhattacharya Clinic, 24/4, Raja Subodh Chandra Mallick Rd, Bidhanpally Jadavpur, Kolkata - 700032, West Bengal, India Kolkata West Bengal
Approved
Indira IVF Hospital Ethics Committee - Kolkata, Dr Partha Sarathi Saha, Dr Partha Sarathi Saha Clinic, Emergency Medical Hall (Personal Chamber), New town, Diamond Harbour, South 24 Paraganas, West bengal, 743331
Approved
Indira IVF Hospital Ethics Committee - Kolkata, Dr Subhasis Roy, Dr Subhasis Roys Clinic, 43, Block B, Block D, Bangur, Lake Town, Kolkata, West Bengal 700055
Approved
Indira IVF Hospital Ethics Committee Lucknow, Dr Ajay Kumar, Hope Mother and Child Care centre, 5 D, AP Sen Rd, Cash, and Pay Colony, Charbagh, Lucknow - 226001., Uttar Pradesh, India Lucknow Uttar Pradesh
Approved
Indira IVF Hospital Ethics Committee – Kolkata, Dr Nyay Bhai Gupta, Shourya Polyclinic And Vaccination Centre, A-98, Infront Of Sundar Bakery, Bhootnath Market, Bhoothnath Market, Lucknow 226016, Uttar Pradesh, India
Approved
Indira IVF Hospital Ethics Committee-- Mumbai, Dr Mukesh Sanklecha, Colaba Clinic, 1st Floor, Sindh Chambers, 9C, near Kailash Parbhat Restaurant, opposite Apollo pharmacy, Colaba, Mumbai - 400005, Maharashtra, India Mumbai Maharashtra
Approved
Indira IVF Hospital Ethics Committee-- Mumbai, Dr Prahalad Samdani, Dr Samdani’s Clinic, No. 217, Mehta House, Pandita Ramabai, Grant Road, Mumbai - 400007, Maharashtra, India Mumbai Maharashtra
Approved
Indira IVF Hospital Ethics Committee-- Mumbai, Dr Sanjeev Parikh, Dr Sanjeev Parikhs Children Hospital, E1 & E2, Sagar Park, Amrut Nagar, Off LBS Marg, Ghatkopar (W), Mumbai- 86, Maharashtra, India
Approved
Indira IVF Hospital Ethics Committee-Lucknow, Dr Tarun Anand, Anand Care Clinic, B-3/289, near Neelkanth sweets, Vivek Khand 3, Gomti Nagar, Lucknow - 226010, Uttar Pradesh, India
Approved
Institutional Ethics Committee, Dr Nirmal Kumar Jain, IHR Guwahati (Goenka Nursing Home), Bharalumukh, Guwahati – 781009, Assam, India Kamrup Assam
Approved
Institutional Ethics Committee, Dr Rekibuddin Ahmed, H M Hospital, Haridev Rd, beside Little flower School, Hatigaon, Guwahati - 781038, Assam, India Kamrup Assam
Approved
Institutional Ethics Committee, Dr Ritesh Kumar Jain, Marwari Hospital, B-3, Sati Joymati Rd, Athgaon, Guwahati – 781008, Assam, India Kamrup Assam
Approved
Ripon Independent Ethics Committee, Dr Amaravathy. Gangadharan Karthikeyan, Sai Mother & Child health centre; Border Thottam, Padupakkam, Triplicane, Chennai-600014, Tamil Nadu, India Chennai Tamil Nadu
Approved
Ripon Independent Ethics Committee, Dr Ayathu Venkata Ravishankar, Child Health Clinic, Dhanwanthri, Old No. 18/1, New no 35, First main road, CIT colony, Mylapore, Chennai – 600004, Tamil Nadu, India Chennai Tamil nadu
Approved
Ripon Independent Ethics Committee, Dr G Shivaraj Babu , G.J.S. Women and Child Care centre, 25/2, Kamaraj Nagar, Main road, Avadi, Chennai – 6000071, Tamil Nadu, India Chennai Tamil Nadu
Patients must meet all of the following criteria to be included in this study:
1) Pediatric patients, aged 2-12 years of age(inclusive of both) of either gender with acute onset of pharyngitis/ tonsillitis/ otitis media as indicated by presence of fever, visiting to outpatient department of pediatrics and whose parents/ Legally acceptable representative (LAR) are ready to participate in the study by signing the written informed consent.
2) Pediatric patients suitable for receiving azithromycin based on investigator’s clinical judgement and locally approved prescribing information.
3) For patients with acute pharyngitis/ tonsillitis/ pharyngo-tonsillitis, presence of at least two specific clinical symptoms and signs such as:
A)Clinical Symptoms: sore throat; pharyngeal erythema; tonsillar erythema
B)Clinical signs: tonsillar enlargement and erythema; tonsillar exudates; painful cervical lymphadenopathy
4) For patients with acute Otitis Media,
A) Presence of middle ear effusion indicated by any of the following:
a) Bulging of tympanic membrane
b) Limited or absent motility of tympanic membrane
c) Air-fluid level behind the tympanic membrane
B) Signs and Symptoms of middle ear inflammation as indicated by either
a) Distinct erythema of tympanic membrane or
b) Distinct otalgia or irritability (discomfort clearly referable to the ears that results in interference with or precludes normal activity or sleep)
ExclusionCriteria
Details
Patients who meet any of the following criteria will be excluded from this study:
1) Pediatric Patients with URTIs those who are not suitable to receive Azithromycin (Allergic, Contraindication, receiving antibiotic other than Azithromycin) based on investigator’s judgement.
2) Patients with LRTIs or any other clinical conditions requiring treatment with antibiotics/ antimicrobials.
3) Participation in any clinical study within 4 weeks prior to enrolment
4) Patient suggestive of complicated Acute otitis media with anyone of :
a)Signs and symptoms of any complication of AOM
b)Otitis externa
c)Tympanostomy tubes presence.
5) Patients not suitable to receive Azithromycin Liquid formulation (Weight of patient above 50 kg)
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Clinical effectiveness to azithromycin will be assessed on the basis of mean reduction in total clinical score for assessing regression of signs & symptoms at 7 ± 1 day
Clinical effectiveness at Day 1(first visit) and Day 7(Follow up visit)
Secondary Outcome
Outcome
TimePoints
1) Number (proportion) of patients showing mean reduction in total clinical score as assessed at 7 ± 1 day evaluated as
A) Cure: Complete disappearance of signs & symptoms present at 7 ± 1 day
B) Improvement: Defervescence with substantial reduction in intensity of signs & symptoms present at 7 ± 1 day & no need of additional antimicrobial therapy
C) Failure: Progression or recurrence of signs & symptoms & introduction of other antimicrobial therapy
2) Safety- Will be assessed based on number & severity of adverse events
3) Compliance assessment– Will be assessed based on medication history (Dose & frequency of intake) at 7 ± 1 day
4) Palatability assessment– Will be as assessed by parents/ legal guardian based on facial hedonic scale 7 ± 1 day
1) Number (proportion) of patients showing mean reduction in total clinical score at 7 ± 1 day
2) Safety assessment at 7 ± 1 day
3) Compliance assessment at 7 ± 1 day
4) Palatability assessment at 7 ± 1 day
Target Sample Size
Total Sample Size="600" Sample Size from India="600" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="533"
Phase of Trial
N/A
Date of First Enrollment (India)
11/05/2025
Date of Study Completion (India)
30/09/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global)
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)?
This multicentric, prospective, open-label, real-world observational study aims to evaluate the effectiveness and safety of Azithral Liquid 200 (Azithromycin oral suspension 200mg/ 5ml) prescribed for 5 days in pediatric patients aged two to twelve years with acute pharyngitis, tonsillitis, or otitis media. The study will recruit 600 pediatric patients with URTIs across multiple centers over a period of four months (April 2025 – July 2025). Patients meeting the inclusion and exclusion criteria will be enrolled after obtaining informed consent from parents or legally acceptable representatives. Each enrolled patient will be assigned a unique allotment number for confidentiality. Azithromycin liquid suspension will be prescribed as per local guidelines and the clinician’s judgment. Patients will have a follow-up visit on Day 7 ± 1; if not feasible, follow-up will be conducted telephonically. Data will be collected using a hard-copy case report form (CRF).