PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Status:
Terminated
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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).