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

Stopped early · Phase 2

Conditions studied: Pharyngitis, Tonsillitis

In brief

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).

Key facts

Study ID

NCT01919996

Run by

Pfizer

People needed

8

Starts

2013-12-01

Expected to finish

2015-11-01

Last updated by the study team

2016-08-05

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Martel Eye Medical Group — Rancho Cordova, California, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Outpatient Center in Lincoln Park — Chicago, Illinois, United States
• Infant Welfare Society of Chicago — Chicago, Illinois, United States
• Murray Pediatrics — Murray, Utah, United States
• Daynes Eye and Lasik — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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