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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-11-30

Brief Summary

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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).

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Detailed Description

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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

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Pharyngitis Tonsillitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin

Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Interventions

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Azithromycin

Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No