PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients

Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis

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).

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.

Inclusion Criteria:

• Male or female patient, aged 12 to 17 years.
• Requires outpatient treatment for acute pharyngitis/tonsillitis infection.
• Appropriate to treat with oral azithromycin as an alternative to intramuscular penicillin, in the opinion of the investigator.
• Positive rapid antigen detection test.

Exclusion Criteria:

• History of clinically significant eye disorder that would interfere with protocol test procedures.
• Hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic.
• Increased risk of QT prolongation.
• Pregnant or breastfeeding.