PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
NCT01919996
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Clearwater, Florida
- Boise, Idaho
- Boise, Idaho
- Boise, Idaho
- Boise, Idaho
- Boise, Idaho
- Meridian, Idaho
- Nampa, Idaho
- Omaha, Nebraska
- Hickory, North Carolina
- Eugene, Oregon
- Bensalem, Pennsylvania
- Harleysville, Pennsylvania
- Salt Lake City, Utah
- Salt Lake City, Utah
- West Jordan, Utah
- Erembodegem,
- Gent,
- Hasselt,
- Nokia,
- Tampere,
- Courbevoie,
- Gentilly,
- Lille,
- Montpellier,
- Rouen,
- Villejuif,
- Berlin,
- Berlin,
- Erkner,
- Ludwigshafen,
- Ruedersdorf,
- Tostedt,
- Villingen-Schwenningen,
- Wuerzburg,
- Bangalore, Karnataka
- Kochi, Kerala
- Hyderabad,
- Pune,
- Foligno, PG
- Gualdo Tadino, PG
- S.Eraclio-Foligno, PG
- Spoleto, PG
- Vocabolo Gaifana-Gualdo Tadino, PG
- Ede (Gld),
- Geldermalsen,
- Huizen,
- Elverum,
- Skedsmokorset,
- Bath, Avon
- Hastings, East Sussex
- Glenrothes, Fife
- High Valleyfield, Fife
- Tunbrige Wells, Kent
- Atherstone, Warwickshire
- Coventry,
- Kent,
- Kent,
- Kent,
- Rancho Cordova, California
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Murray, Utah
- Salt Lake City, Utah
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients | |||
Official Title ICMJE | Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis | |||
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). | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Azithromycin
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days | |||
Study Arms ICMJE | Experimental: Azithromycin
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days Intervention: Drug: Azithromycin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 8 | |||
Original Estimated Enrollment ICMJE | 36 | |||
Actual Study Completion Date ICMJE | November 2015 | |||
Actual Primary Completion Date | October 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 12 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01919996 | |||
Other Study ID Numbers ICMJE | A0661206 208291 ( Other Identifier: Alias Study Number ) 2016-001119-19 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |