Trial · NCT01919996
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
NCT01919996, Phase 2, Terminated, Pfizer; results first posted 2016-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients. Trials, record NCT01919996. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01919996
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
- NCT number
- NCT01919996
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pharyngitis, Tonsillitis
- Interventions
- Azithromycin
- First posted
- 2013-08-09
- Last updated
- 2016-08-05
- Other registries' IDs
- eudract:2016-001119-19
- Results first posted
- 2016-07-06
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations | 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. |
| Secondary | Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations | 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. |
| Secondary | Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations | 14 days | 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). | percentage of participants | NUMBER |
| SECONDARY | Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations | 14 days | 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). | percentage of participants | NUMBER |
| SECONDARY | Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations | 14 days | 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). | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations | Azithromycin | Clinically significant worsening - Yes | 0.0 | percentage of participants | |
| Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations | Azithromycin | Clinically significant worsening - No | 87.5 | percentage of participants | |
| Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations | Azithromycin | Not Evaluable | 12.5 | percentage of participants | |
| Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations | Azithromycin | Clinically Significant Improvement - Yes | 12.5 | percentage of participants | |
| Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations | Azithromycin | Clinically Significant Improvement - No | 75.0 | percentage of participants | |
| Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations | Azithromycin | Not Evaluable | 12.5 | percentage of participants | |
| Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations | Azithromycin | Significant Change (Improvement or Worsening) -Yes | 12.5 | percentage of participants | |
| Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations | Azithromycin | Significant Change (Improvement or Worsening) - No | 75.0 | percentage of participants | |
| Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations | Azithromycin | Not Evaluable | 12.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin | 8 | |
| Overall Study | COMPLETED | Azithromycin | 8 | |
| Overall Study | NOT COMPLETED | Azithromycin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin | ||
| Total, other adverse events | Azithromycin | 0 | 8 |
| Total, serious adverse events | Azithromycin | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01919996
GET https://conductscience.org/api/trials/v1/NCT01919996/registered