CTRI/2023/08/056267 [Registered on: 08/08/2023] Trial Registered Prospectively
Last Modified On:
04/10/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Effects of Amoxycillin and Potassium Clavulanate Oral Syrup in Children With Respiratory Infection
Scientific Title of Study
A Prospective, Multi-center, Single-arm, Phase IV Study to Assess the Safety & Efficacy of Amoxycillin and Potassium Clavulanate Oral Suspension in Children With Upper Respiratory Tract Infection (URTI) or Lower Respiratory Tract Infection (LRTI)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/22/010 Version No. 1.0 dated 16/DEC/2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President & Head - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
9819767704
Fax
02243244323
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Shruti Saha
Designation
Manager - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
shruti.saha@sunpharma.com
Details of Contact Person Public Query
Name
Sucheta A Pandit
Designation
Deputy General Manager - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E),
Mumbai - 400063, Maharashtra, India.
11 & 30, Ward no. 6, Ground Floor, Department of Pediatrics, Ramaiah complex, Bhuvamneshwari Nagar Main Road, H A Farm Post, Dasarahalli, Bengaluru560024, Karnataka, India. Bangalore KARNATAKA
9844004187
eeshaclinicalresearch@gmail.com
Dr Richa Giri
GSVM Medical College
HOD Room, Ground floor, Postgraduate Department of Medicine, GSVM Medical college, Swaroop Nagar, Kanpur nagar-208002, Uttar Pradesh, India. Kanpur Nagar UTTAR PRADESH
8400331045
drichagiri.gsvm@gmail.com
Dr Ashil Dilipbhai Manavadaria
Hi-Tech Multispeciality Hospital
Ground Floor, Department of Pediatric, Sector 3-D, Plot no. 1180, Gh Road, Nr. Gh-11/2 Bus Stand, Gandhinagar, Gujarat-382003, India Gandhinagar GUJARAT
9428047470
drashil.man@gmail.com
Dr Monjori Mitra
Institute of Child Health
Room No. 110, Ground Floor, Department of Medicine, 11, Dr. Biresh Guha Street, Kolkata-700017 Kolkata WEST BENGAL
9831075734
monjorimr@gmail.com
Dr Prakash K Wari
Karnataka Institute of Medical Sciences
Room No.103, Department of Pediatric, Vidyanagar, Hubli-580021 Dharwad KARNATAKA
8904642255
pkwari@rediffmail.com
Dr Gupta Sandeep Kumar
M.V Hospital and Research Centre
Ground Floor, Department of Pediatrics, 314/30, Mirza Mandi, Chowk, Lucknow-226003, Uttar Pradesh,
India. Lucknow UTTAR PRADESH
9336077839
sandeepkumar.gupta@rediffmail.com
Dr Sumarpriya M
Malla Reddy Narayana Multispeciality Hospital
Clinical Research Unit, 2nd floor, Room no. 2A, Department of Pediatrics, Suraram X Roads, Jeedimetla, Hyderabad-500055 Hyderabad TELANGANA
7675892222
drsumapriya222@gmail.com
Dr Prashanth MV
Medstar Speciality Hospital
Ground floor, Pediatrics Ward, #641/17/1/3, Kodigehalli Main Road, Sahakarnagar, Bangalore-560092, Karnataka, India. Bangalore KARNATAKA
9480390855
medstarclinicalresearch@gmail.com
Dr Jitendra Shukla
Motilal Nehru Medical College
George Town, Room. 101, Department of Medicine, Civil Lines, Prayagraj, Allahabad, Uttar Pradesh-211002. Allahabad UTTAR PRADESH
8527483335
drjeetendramln@gmail.com
Dr Neeraj Kumar
S. N Medical College
Ground floor, Department of Pediatrics, Moti Katra, Agra 282003, UP India. Agra UTTAR PRADESH
9756966669
neerajyadu@rediffmail.com
Dr Rajib Kumar Ray
Sparsh Hospital and Critical Care. Pvt. Ltd
Ground floor, Room No. 2, Department of Medicine, Plot No. A/407, Sahid Nagar Bhuwaneshwar, Odisha-751007 Cuttack ORISSA
9338089618
drrajib2007@gmail.com
Dr Saurabh Gandhi
SVP Hospital
First floor C-1, Department of Pediatric, Smt NHL Medical College and SVP Institute of Medical Sciences & Research Ellis Bridge. Ahmedabad 380006. Ahmadabad GUJARAT
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Amoxycillin 600 mg per 5 mL and Potassium Clavulanate 42.9 mg per 5 mL Oral Suspension
Oral suspension to be administered according to weight of the child (45 mg Amoxycillin and 3.2 mg Potassium clavulanate per kg per dose) every 12 hours. To be administered orally twice daily for 5 to 10 days depending on diagnosis and severity of symptoms.
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
3.00 Year(s)
Age To
18.00 Year(s)
Gender
Both
Details
1. Children of either gender, aged between ≥3 months and <18 years, and weight less than 40 kg
2. Confirmed clinical diagnosis of URTI [acute otitis media (AOM) OR tonsillo-pharyngitis OR acute bacterial sinusitis] OR LRTI [lobar pneumonia and/or bronchopneumonia] for which patient require treatment with Amoxycillin and Potassium Clavulanate Oral Suspension based on Investigator’s opinion
3. Parent/Legal guardian is willing to give written informed consent and patient willing to give oral assent if aged 7 to <12 years and written assent if aged ≥12 years
4. Patient able to swallow study medications and follow study protocol
5. For females of childbearing potential, parents should confirm that the patient is not pregnant and investigator should also confirm the same. In case of any doubt, investigator should conduct urine pregnancy test (UPT).
Note: However, if pregnancy is detected any time after enrolment, then parents should inform the investigator and the patient should be withdrawn from the study.
ExclusionCriteria
Details
1. Patients weighing >40 kg
2. Suspicion of non-infectious or viral aetiology
3. Patients with complicated URTI/ LRTI requiring intravenous antibiotics or hospitalisation
4. Patient with history of prior lung conditions
5. Patient with history of pulmonary tuberculosis
6. Patient having history of hypersensitivity to penicillin or any beta-lactam antibiotics
7. Patient having history of amoxycillin-clavulanate associated cholestatic jaundice/ hepatic impairment
8. Patient having history of bleeding disorder or currently on anticoagulants
9. Patient with history of phenylketonuria
10. Patient undergoing haemodialysis
11. Patients on probenecid or allopurinol
12. Patients with any clinically significant condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
13. Patients with high risk of carrying amoxycillin-resistant organisms [received amoxycillin or penicillin or other beta-lactam antimicrobials in the last 30 days, OR history of methicillin-resistant Staphylococcus aureus (MRSA) infection]
14. Patient using other antimicrobials in last 30 days
15. Patient with history or current signs and symptoms suggestive of renal impairment (e.g., puffiness of face, pedal oedema, ascites, abnormal urine output etc.)
16. Patient with history or current signs and symptoms suggestive of hepatic impairment (e.g., icterus, anemia, ascites, pain in abdomen, abnormal internal bleeding etc.)
17. Patient with history or current serious underlying disease like but not limited to epilepsy, congenital disorder, metabolic disorder, cardiovascular disease, hepatic disorder, renal disorder, intestinal perforation or obstruction, congenital gastro-intestinal malformation, genito-urinary disorder etc.
18. Concomitant infection which would preclude evaluation of the response of his/her URTI/ LRTI to the study intervention.
19. Patient with history of Human Immunodeficiency Virus (HIV) and / or Hepatitis B and/ or Hepatitis C
20. Patients with other disease or medication leading to immune-compromised condition
21. Patient with history of significant active peptic ulceration
22. Patient with history of cancer or undergoing cancer chemo or radiotherapy
23. Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study
24. Patient with known alcohol or other substance abuse within last one year
25. Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of participants with treatment-emergent adverse events (TEAEs)
Throughout the study period
Secondary Outcome
Outcome
TimePoints
Proportion of participants with serious adverse events (SAEs)
Throughout the study period
Proportion of participants with diarrhoea
Throughout the study period
Proportion of patients achieving clinical cure
End of study
Proportion of patients with clinical failure
End of study
Proportion of patients with clinical improvement
End of study
Proportion of patients with clinical relapse
End of study
Time to symptom resolution (based on patient report)
Day 1 to End of study
Target Sample Size
Total Sample Size="174" Sample Size from India="174" 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
Phase 4
Date of First Enrollment (India)
18/08/2023
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
This is a Phase 4, single-arm, multicenter study. The study will be conducted at approximately 10 to 15 number of centers in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval. After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment. After confirming the eligibility, patients will be administered Test product, i.e., Amoxycillin and Potassium Clavulanate Oral Suspension (600 mg + 42.9 mg/5 ml) twice daily (every 12 hours) for 5-10 days depending on diagnosis and severity of symptoms. After 5 to 10 days of treatment, end of study visit will be conducted on Day 5 to 10 (+4 days) based on the last dose of test product administered. During the study, assessments will be performed as mentioned in Schedule of Assessment.