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What is the primary objective of this study?

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).

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pharyngitis

Tonsillitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AzithromycinAzithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Terminated

Start Date: December 2013

Completed Date: November 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations

Secondary Outcome: Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01919996