PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients - Full Text View

Purpose

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	Intervention	Phase
Pharyngitis Tonsillitis	Drug: Azithromycin	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat Tonsils and Adenoids

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
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:

Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
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.
Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
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.


Enrollment:	8
Study Start Date:	December 2013
Study Completion Date:	November 2015
Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	12 Years to 17 Years (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919996

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

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01919996 History of Changes
Other Study ID Numbers:	A0661206 208291 2016-001119-19
Study First Received:	August 7, 2013
Results First Received:	March 28, 2016
Last Updated:	July 6, 2016
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016