Conditions: Pharyngitis Tonsillitis
Keywords: Ocular safety azithromycin pharyngitis tonsillitis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory post-marketing requirement to provide data regarding visual abilities in children taking azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary objective of the study is to examine the incidence of clinically significant worsening in any of the following ophthalmic exams: best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of approximately 30 pediatric patients taking azithromycin oral solution for treatment of an authorized indication of use (pharyngitis/ tonsillitis).

Detailed description:
Study was terminated prematurely on October 16, 2015 following FDA decision to release Sponsor from post-marketing commitment. No safety and/or efficacy concerns identified.

Arms:
arm 1: Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Interventions: intervention 1: Azithromycin
Intervention descriptions: intervention 1: Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Protocol document: