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

Pharyngitis Clinical Trial

Official title:

Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01919996
• Other study ID #: A0661206
• Secondary ID: 208291
• Status: Terminated
• Phase: Phase 2
• First received: August 7, 2013
• Last updated: February 23, 2016
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis
• Tonsillitis

Intervention

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

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Infant Welfare Society of Chicago	Chicago	Illinois
United States	Outpatient Center in Lincoln Park	Chicago	Illinois
United States	Murray Pediatrics	Murray	Utah
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Daynes Eye and Lasik	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination	Incidence of clinically significant worsening of any of these examinations	14 days	Yes
Secondary	Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination	Incidence of clinically significant improvement of any of these examinations	14 days	Yes
Secondary	Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination	Incidence of clinically significant change (improvement or worsening) in any of these examinations	14 days	Yes

External Links

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