Status:
TERMINATED
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Lead Sponsor:
Pfizer
Conditions:
Pharyngitis
Tonsillitis
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
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...
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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01919996
Start Date
December 1 2013
End Date
November 1 2015
Last Update
August 5 2016
Active Locations (6)
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1
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
2
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
3
Outpatient Center in Lincoln Park
Chicago, Illinois, United States, 60614
4
Infant Welfare Society of Chicago
Chicago, Illinois, United States, 60647