Pharyngitis | PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Pharyngitis research study
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?
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
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
Start Date: December 2013
Completed Date: November 2015
Phase: Phase 2
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