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

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
|
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919996
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
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 Key Record Dates |
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 |