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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharyngitis; Tonsillitis

Intervention: Azithromycin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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).

Clinical Details

Official title: Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination

Secondary outcome:

Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination

Best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

NEA Baptist Clinic, Jonesboro, Arkansas 72401, United States; Recruiting

Elk Grove Pediatrics Inc., Elk Grove, California 95624, United States; Recruiting

Martel Eye Medical Group, Rancho Cordova, California 95670, United States; Terminated

Barbara J. Arnold, Inc., Sacramento, California 95823, United States; Recruiting

Benchmark Research, Sacramento, California 95822, United States; Recruiting

South Area Pediatrics, Inc, Sacramento, California 95823, United States; Recruiting

Chiefland Medical Center, Chiefland, Florida 32626, United States; Recruiting

North Florida Eye Center, Chiefland, Florida 32626, United States; Recruiting

Palms Medical Group, Chiefland, Florida 32626, United States; Recruiting

Southeast Clinical Research, LLC, Chiefland, Florida 32626, United States; Recruiting

North Florida Eye Center, Gainesville, Florida 32605, United States; Recruiting

Atlanta Eye Consultants, PC, Atlanta, Georgia 30308, United States; Recruiting

Polaris Medical Group, LLC, Atlanta, Georgia 30331, United States; Recruiting

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois 60611, United States; Recruiting

Infant Welfare Society of Chicago, Chicago, Illinois 60647, United States; Recruiting

Outpatient Center in Lincoln Park, Chicago, Illinois 60614, United States; Recruiting

Murray Pediatrics, Murray, Utah 84107, United States; Terminated

Daynes Eye and Lasik, Salt Lake City, Utah 84124, United States; Terminated

Additional Information

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

Starting date: December 2013
Last updated: August 21, 2015

Page last updated: August 23, 2015

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