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: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Azithromycin

Criteria

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.