NCT01919996

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pharyngitis
• Tonsillitis

Interventions

Type	Name	Description
DRUG	Azithromycin	Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2013-08-09
• Last updated: 2016-08-05
• Results posted: 2016-07-06

Locations

6 sites across 1 country: United States