Trials / Withdrawn
WithdrawnNCT05340257
A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics and Safety of Augmentin Extra Strength (ES)-600 Suspension in Children Presenting With Community Acquired Pneumonia (CAP) and Acute Bacterial Rhinosinusitis (ABRS) in Brazil
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 3 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the pharmacokinetics, safety or tolerability through treatment emergent adverse event (TEAE) and to explore primary and secondary clinical response of treatment with Augmentin ES in pediatric population presenting with CAP and ABRS in Brazil.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Augmentin ES | Amoxicillin and clavulanic acid in fixed dose combination will be administered |
Timeline
- Start date
- 2023-10-14
- Primary completion
- 2024-07-08
- Completion
- 2024-07-08
- First posted
- 2022-04-22
- Last updated
- 2025-03-28
Locations
2 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05340257. Inclusion in this directory is not an endorsement.