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

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ClinicalTrials.gov Identifier: NCT01919996
Recruitment Status : Terminated (See Termination Statement in the Detailed Description below)
First Posted : August 9, 2013
Results First Posted : July 6, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 7, 2013
First Posted Date  ICMJE August 9, 2013
Results First Submitted Date  ICMJE March 28, 2016
Results First Posted Date  ICMJE July 6, 2016
Last Update Posted Date August 5, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pharyngitis
  • Tonsillitis
Intervention  ICMJE Drug: Azithromycin
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
Study Arms  ICMJE Experimental: Azithromycin
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
Intervention: Drug: Azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 7, 2015)
8
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2013)
36
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01919996
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP