Clinical trial NCT01919996: PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Official title: Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pharyngitis
Tonsillitis
Keywords: Ocular safety
azithromycin
pharyngitis
tonsillitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations
timeFrame: 14 days
Secondary outcomes:
measure: Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations
timeFrame: 14 days
measure: Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations
timeFrame: 14 days
Other outcomes:
Locations:
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Outpatient Center in Lincoln Park
state: Illinois
city: Chicago
country: United States
facility: Infant Welfare Society of Chicago
state: Illinois
city: Murray
country: United States
facility: Murray Pediatrics
state: Utah
city: Salt Lake City
country: United States
facility: Daynes Eye and Lasik
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: