Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05340257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2022-04-15
Brief Title:
A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None