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

Status:	Terminated
Conditions:	Cancer, Other Indications, Other Indications
Therapuetic Areas:	Oncology, Other
Healthy:	No
Age Range:	12 - 17
Updated:	4/21/2016
Start Date:	December 2013
End Date:	November 2015

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.

We found this trial at

sites

Ann & Robert H. Lurie Children's Hospital of Chicago

225 E Chicago Ave
Chicago, Illinois 60611

(312) 227-4000