# Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India

> **NCT04600752** · PHASE4 · COMPLETED · sponsor: **GlaxoSmithKline** · enrollment: 310 (actual)

## Conditions studied

- Otitis Media
- Infections, Respiratory Tract
- Respiratory Tract Infections

## Interventions

- **DRUG:** Augmentin (ES)-600

## Key facts

- **NCT ID:** NCT04600752
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-05-07
- **Primary completion:** 2022-11-12
- **Final completion:** 2022-11-12
- **Target enrollment:** 310 (ACTUAL)
- **Last updated:** 2024-06-10

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04600752

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04600752, "Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04600752. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*