Clinical Outcomes with High-Dose Amoxycillin–Clavulanate Suspension in Children with Respiratory Tract Infections: A Prospective, Multicentre, Phase IV Study in India
13 affiliations
- 1Sparsh Hospital and Critical Care, Bhubaneswar, India
- 2Hi-Tech Multispeciality Hospital, Gandhinagar, India
- 3Institute of Child Health, Kolkata, India
- 4SVP Hospital, Smt. NHL Medical College and SVP Institute of Medical Sciences & Research Ellis Bridge, Ahmedabad, India
- 5S. N. Medical College, Agra, India
- 6Karnataka Institute of Medical Science, Hubli, India
- 7GSVM Medical College, Kanpur, India
- 8Eesha Multispeciality Hospital, Bengaluru, India
- 9Malla Reddy Narayana Multispeciality Hospital, Hyderabad, India
- 10Motilal Nehru Medical College, Allahabad, India
- 11Medstar Speciality Hospital, Bengaluru, India
- 12M. V. Hospital and Research Centre, Lucknow, India
- 13Medical Affairs and Clinical Research, Sun Pharma Laboratories Limited, ‘Sun House’, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai, Maharashtra 400063 India
Abstract
Introduction: Respiratory tract infections (RTIs) are the leading causes of paediatric morbidity worldwide, particularly in regions with high antimicrobial resistance (AMR). High-dose amoxycillin–clavulanate formulations, which increase amoxycillin exposure while maintaining standard clavulanate levels, offer enhanced antibacterial coverage with acceptable tolerability. This phase IV study evaluated the safety and observed clinical outcomes of a high-dose oral suspension of amoxycillin (600 mg/5 mL) and potassium clavulanate (42.9 mg/5 mL) in Indian children with upper RTIs or non-severe lower RTIs.
Methods: This prospective, multicentre, open-label study enrolled children aged ≥ 3 months to < 18 years with tonsillopharyngitis, acute bacterial sinusitis, acute otitis media, or lobar and/or bronchopneumonia across 12 Indian centres. Participants received amoxycillin–clavulanate at 90/6.4 mg/kg/day in two divided doses for 5–10 days. The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs). Secondary endpoints included serious adverse events (SAEs), diarrhoea incidence, clinical cure, clinical improvement, clinical failure, clinical relapse and time to symptom resolution. Safety analyses used the safety population, while clinical outcomes were analysed using the modified intention-to-treat population.
Results: All 174 enrolled children completed the study. Overall, 21 patients (12.1%) experienced 23 TEAEs (all mild and self-limiting). No SAEs, discontinuations or clinically significant laboratory or vital sign changes were reported. Diarrhoea occurred in 6.3% of patients. Overall clinical cure rate was 82.8% (95% CI 76.3–88.1), highest in acute bacterial sinusitis (95.8%), tonsillopharyngitis (83.7%), acute otitis media (76.9%) and pneumonia (76.5%). An additional 17.2% demonstrated clinical improvement without the need for alternative therapy. No clinical failures or relapses were observed. Overall median time to symptom resolution was 6 days.
Conclusion: High-dose amoxycillin–clavulanate demonstrated a favourable safety profile. Observed clinical outcomes were favourable, with a clinical cure or improvement rate of 100% across all patients. These findings provide post-marketing safety and tolerability data to support clinical decision-making in settings with rising AMR.
Trial Registration: Prospectively registered on Clinical Trials Registry—India [CTRI/2023/08/056267] on 08th August 2023; URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODY5MzI=&Enc=&userName=.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s12325-026-03722-0.
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BibTeX
@article{ray2026clinical,
title = {{Clinical Outcomes with High-Dose Amoxycillin–Clavulanate Suspension in Children with Respiratory Tract Infections: A Prospective, Multicentre, Phase IV Study in India}},
author = {Rajib Ray and Ashil Dilipbhai Manavadaria and Monjori Mitra and Saurabh Gandhi and Neeraj Yadav and Prakash Wari and Richa Giri and Chikkalingaiah Siddegowda and Suma Priya Molugu and Jitendra Shukla and M. V. Prashanth and Sandeep Kumar Gupta and Apurva Shetty and Shruti Saha and Supriya Sonowal and Sucheta Pandit and Dipak Patil and Gaurav Puppalwar and Pravin Ghadge and Suyog Mehta},
journal = {Advances in Therapy},
year = {2026},
month = aug,
doi = {10.1007/s12325-026-03722-0},
url = {https://doi.org/10.1007/s12325-026-03722-0},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Clinical Outcomes with High-Dose Amoxycillin–Clavulanate Suspension in Children with Respiratory Tract Infections: A Prospective, Multicentre, Phase IV Study in India
AU - Rajib Ray
AU - Ashil Dilipbhai Manavadaria
AU - Monjori Mitra
AU - Saurabh Gandhi
AU - Neeraj Yadav
AU - Prakash Wari
AU - Richa Giri
AU - Chikkalingaiah Siddegowda
AU - Suma Priya Molugu
AU - Jitendra Shukla
AU - M. V. Prashanth
AU - Sandeep Kumar Gupta
AU - Apurva Shetty
AU - Shruti Saha
AU - Supriya Sonowal
AU - Sucheta Pandit
AU - Dipak Patil
AU - Gaurav Puppalwar
AU - Pravin Ghadge
AU - Suyog Mehta
PY - 2026
DA - 2026/08/05
JO - Advances in Therapy
DO - 10.1007/s12325-026-03722-0
UR - https://doi.org/10.1007/s12325-026-03722-0
AB - Introduction: Respiratory tract infections (RTIs) are the leading causes of paediatric morbidity worldwide, particularly in regions with high antimicrobial resistance (AMR). High-dose amoxycillin–clavulanate formulations, which increase amoxycillin exposure while maintaining standard clavulanate levels, offer enhanced antibacterial coverage with acceptable tolerability. This phase IV study evaluated the safety and observed clinical outcomes of a high-dose oral suspension of amoxycillin (600 mg/5 mL) and potassium clavulanate (42.9 mg/5 mL) in Indian children with upper RTIs or non-severe lower RTIs. Methods: This prospective, multicentre, open-label study enrolled children aged ≥ 3 months to < 18 years with tonsillopharyngitis, acute bacterial sinusitis, acute otitis media, or lobar and/or bronchopneumonia across 12 Indian centres. Participants received amoxycillin–clavulanate at 90/6.4 mg/kg/day in two divided doses for 5–10 days. The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs). Secondary endpoints included serious adverse events (SAEs), diarrhoea incidence, clinical cure, clinical improvement, clinical failure, clinical relapse and time to symptom resolution. Safety analyses used the safety population, while clinical outcomes were analysed using the modified intention-to-treat population. Results: All 174 enrolled children completed the study. Overall, 21 patients (12.1%) experienced 23 TEAEs (all mild and self-limiting). No SAEs, discontinuations or clinically significant laboratory or vital sign changes were reported. Diarrhoea occurred in 6.3% of patients. Overall clinical cure rate was 82.8% (95% CI 76.3–88.1), highest in acute bacterial sinusitis (95.8%), tonsillopharyngitis (83.7%), acute otitis media (76.9%) and pneumonia (76.5%). An additional 17.2% demonstrated clinical improvement without the need for alternative therapy. No clinical failures or relapses were observed. Overall median time to symptom resolution was 6 days. Conclusion: High-dose amoxycillin–clavulanate demonstrated a favourable safety profile. Observed clinical outcomes were favourable, with a clinical cure or improvement rate of 100% across all patients. These findings provide post-marketing safety and tolerability data to support clinical decision-making in settings with rising AMR. Trial Registration: Prospectively registered on Clinical Trials Registry—India [CTRI/2023/08/056267] on 08th August 2023; URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODY5MzI=&Enc=&userName=. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s12325-026-03722-0.
SN - 0741-238X
SN - 1865-8652
ER -