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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Pharyngitis; Tonsillitis	Drug: Azithromycin	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis
Study Start Date :	December 2013
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	November 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Azithromycin; Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days	Drug: Azithromycin; Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Outcome Measures

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Primary Outcome Measures :

1. Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations [ Time Frame: 14 days ]
   Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.

Secondary Outcome Measures :

1. Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations [ Time Frame: 14 days ]
   1 or more of these conditions are clinically significant improvement based on five ophthalmic exams:1) clinically significant improvement in BCVA(distance) at the final visit, in either eye, defined as an increase in score of 5 or more letters from baseline in ETDRS BCVA.2) Assessment of abnormal clinically significant at baseline and normal or abnormal, non-clinically significant at final visit in color vision(FM-100) in either eye. 3) Assessment of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5)Assessments of abnormal clinically significant at baseline and normal/abnormal, nonclinically significant at final visit in dilated ophthalmoscopy in any of the 5 eye structures in either eye.
2. Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations [ Time Frame: 14 days ]
   Clinically significant change (improvement or worsening) is based on five ophthalmic exams at baseline and the final visit. Any 1 or more of these conditions are a clinically significant change: 1) A worsening in BCVA (distance), as defined in outcome measure 1 OR an improvement in BCVA (distance) as defined in outcome measure 2. 2) A worsening in color vision (FM-100), as defined in outcome measure 1 OR an improvement in color vision (FM-100) as defined in outcome measure 2. 3) A worsening in Amsler Grid, as defined in outcome measure 1, OR an improvement in Amsler Grid, as defined in outcome measure 2. 4) A worsening in anterior segment biomicroscopy, as defined in outcome measure 1 OR an improvement in anterior segment biomicroscopy as defined in outcome measure 2. 5) A worsening in dilated indirect ophthalmoscopy, as defined in outcome measure 1 OR an improvement in dilated indirect ophthalmoscopy as defined in outcome measure 2.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Outpatient Center in Lincoln Park
Chicago, Illinois, United States, 60614
Infant Welfare Society of Chicago
Chicago, Illinois, United States, 60647
United States, Utah
Murray Pediatrics
Murray, Utah, United States, 84107
Daynes Eye and Lasik
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01919996 History of Changes
Other Study ID Numbers:	A0661206; 208291 ( Other Identifier: Alias Study Number ); 2016-001119-19 ( EudraCT Number )
First Posted:	August 9, 2013
Results First Posted:	July 6, 2016
Last Update Posted:	August 5, 2016
Last Verified:	July 2016

Keywords provided by Pfizer:

Ocular safety; azithromycin; pharyngitis; tonsillitis

Additional relevant MeSH terms:

Pharyngitis; Tonsillitis; Pharyngeal Diseases; Stomatognathic Diseases	Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases