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

NCT01919996 | Terminated Phase 2 Results

• 3 other identifiers: A06612062082912016-001119-19
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 6

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).

Conditions

Pharyngitis; Tonsillitis

Keywords

Ocular safety; azithromycin; pharyngitis; tonsillitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations

  14 days

• Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations

  14 days

Study Arms (1)

Azithromycin

EXPERIMENTAL

Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Drug: Azithromycin

Interventions

Azithromycin DRUG

Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Azithromycin

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Outpatient Center in Lincoln Park

Chicago, Illinois, 60614, United States

Location

Infant Welfare Society of Chicago

Chicago, Illinois, 60647, United States

Location

Murray Pediatrics

Murray, Utah, 84107, United States

Location

Daynes Eye and Lasik

Salt Lake City, Utah, 84124, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pharyngitis; Tonsillitis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 5, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-07

Locations

US (6)