Ignite Creation Date:
2024-05-06 @ 1:55 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01934231
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2013-08-29
Brief Title:
Study to Assess the Efficacy and Safety of Potassium ClavulanateAmoxicillin in Children With Acute Bacterial Rhinosinusitis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicenter Open-Label Study To Assess The Efficacy And Safety Of Potassium ClavulanateAmoxicillin CVAAMPC 114 Combination In The Treatment Of Children With Acute Bacterial Rhinosinusitis
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Acute Bacterial Rhinosinusitis ABRS is a respiratory inflammation commonly seen in clinical practice which has with respiratory symptoms including nasal congestion rhinorrhoea postnasal discharge and cough and is associated with headache cheek pain facial pressure and other conditions The principal bacterial pathogens in causing ABRS include Streptococcus pneumoniae Haemophilus influenzae and Moraxella Branhamella catarrhalis These three bacteria account for approximately 90 of ABRS in children less than or equal to 5 years of age Combination of Potassium Clavulanate CVA and Amoxicillin AMPC produces higher antibiotic activity against beta-lactamase-producing bacteria The present study is designed to assess the clinical efficacy bacteriological efficacy and safety of CVAAMPC 114 administered in children aged from 3 months to less than 15 years with ABRS It is an open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase for 7 to 14 days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None