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

• ClinicalTrials.gov Identifier: NCT01919996
• Recruitment Status: Terminated
• First Posted: August 9, 2013
• Results First Posted: July 6, 2016
• Last Update Posted: August 5, 2016
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: August 7, 2013
• First Posted Date: August 9, 2013
• Results First Submitted Date: March 28, 2016
• Results First Posted Date: July 6, 2016
• Last Update Posted Date: August 5, 2016
• Study Start Date: December 2013
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2016)

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.

Original Primary Outcome Measures (submitted: August 7, 2013)

Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination [ Time Frame: 14 days ]

Incidence of clinically significant worsening of any of these examinations

Current Secondary Outcome Measures (submitted: May 25, 2016)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: August 7, 2013)

• Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination [ Time Frame: 14 days ]
  Incidence of clinically significant improvement of any of these examinations
• Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination [ Time Frame: 14 days ]
  Incidence of clinically significant change (improvement or worsening) in any of these examinations

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pharyngitis
• Tonsillitis

Intervention

Drug: Azithromycin

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

Study Arms

Experimental: Azithromycin

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

Intervention: Drug: Azithromycin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 7, 2015): 8
• Original Estimated Enrollment (submitted: August 7, 2013): 36
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01919996
• Other Study ID Numbers: A0661206; 208291 ( Other Identifier: Alias Study Number ); 2016-001119-19 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2016