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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01919996
First received: August 7, 2013
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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).

Condition Intervention Phase
Pharyngitis
Tonsillitis
Drug: Azithromycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Incidence of clinically significant worsening of any of these examinations


Secondary Outcome Measures:
  • Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Incidence of clinically significant improvement of any of these examinations

  • Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Incidence of clinically significant change (improvement or worsening) in any of these examinations


Enrollment: 8
Study Start Date: December 2013
Study Completion Date: November 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919996

Locations
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01919996     History of Changes
Other Study ID Numbers: A0661206  208291 
Study First Received: August 7, 2013
Last Updated: February 23, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Ocular safety
azithromycin
pharyngitis
tonsillitis

Additional relevant MeSH terms:
Pharyngitis
Tonsillitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 24, 2016