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| ID | Type | Description | Link |
|---|---|---|---|
| 208291 | Other Identifier | Alias Study Number | |
| 2016-001119-19 | EudraCT Number |
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See Termination Statement in the Detailed Description below
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations | 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States | ||
| Ann & Robert H. Lurie Children's Hospital of Chicago |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety population included all enrolled participants that took at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations | 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. | 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). | Posted | Number | percentage of participants | 14 days |
Day 1 up to 28 calendar days after the last administration of the study medication (up to 40 days)
The safety population included all enrolled participants that took at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| 14 days |
| Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations | 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. | 14 days |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Outpatient Center in Lincoln Park | Chicago | Illinois | 60614 | United States |
| Infant Welfare Society of Chicago | Chicago | Illinois | 60647 | United States |
| Murray Pediatrics | Murray | Utah | 84107 | United States |
| Daynes Eye and Lasik | Salt Lake City | Utah | 84124 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Azithromycin | 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. |
|
|
| Secondary | Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations | 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. | 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). | Posted | Number | percentage of participants | 14 days |
|
|
|
| Secondary | Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations | 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. | 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). | Posted | Number | percentage of participants | 14 days |
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|
| 0 |
| 8 |
| 0 |
| 8 |
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.
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Organic Chemicals |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|