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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pharyngitis
Tonsillitis
Intervention Drug: Azithromycin
Enrollment 8
Recruitment Details The sample size of 30 completed participants was specified by Food and Drug Administration (FDA) in the Post Marketing Commitment (PMC). Of the 30 pediatric participants planned for the study, 11 were screened and 8 participants received study treatment.
Pre-assignment Details This was a prospective, non-comparative, open-label, single-arm study of azithromycin oral solution in 30 pediatric participants (aged 12 to 17 years) with pharyngitis/ tonsillitis who could be treated with azithromycin for their infection. The study design was intended to align with request from FDA to conduct the study.
Arm/Group Title Azithromycin
Hide Arm/Group Description All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Azithromycin
Hide Arm/Group Description All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
The safety population included all enrolled participants that took at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
14.4  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
6
  75.0%
Male
2
  25.0%
1.Primary Outcome
Title Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).
Arm/Group Title Azithromycin
Hide Arm/Group Description:
All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
Clinically significant worsening - Yes 0.0
Clinically significant worsening - No 87.5
Not Evaluable 12.5
2.Secondary Outcome
Title Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).
Arm/Group Title Azithromycin
Hide Arm/Group Description:
All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
Clinically Significant Improvement - Yes 12.5
Clinically Significant Improvement - No 75.0
Not Evaluable 12.5
3.Secondary Outcome
Title Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).
Arm/Group Title Azithromycin
Hide Arm/Group Description:
All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
Significant Change (Improvement or Worsening) -Yes 12.5
Significant Change (Improvement or Worsening) - No 75.0
Not Evaluable 12.5
Time Frame Day 1 up to 28 calendar days after the last administration of the study medication (up to 40 days)
Adverse Event Reporting Description The safety population included all enrolled participants that took at least one dose of study medication.
 
Arm/Group Title Azithromycin
Hide Arm/Group Description All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
All-Cause Mortality
Azithromycin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Azithromycin
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azithromycin
Affected / at Risk (%)
Total   0/8 (0.00%) 
The study was terminated after the FDA released the Sponsor from the PMC. The FDA deemed the study as impracticable, given the azithromycin dose studied in the PMC was not used and the available data did not identify a signal for ocular toxicity.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01919996    
Other Study ID Numbers: A0661206
208291 ( Other Identifier: Alias Study Number )
2016-001119-19 ( EudraCT Number )
First Submitted: August 7, 2013
First Posted: August 9, 2013
Results First Submitted: March 28, 2016
Results First Posted: July 6, 2016
Last Update Posted: August 5, 2016