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

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NCT01919996

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Martel Eye Medical Group
Rancho Cordova, California, 95670 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharyngitis, Tonsillitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01919996
Pfizer
Terminated
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients

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PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/Tonsillitis
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).
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pharyngitis
  • Tonsillitis
Drug: Azithromycin
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
Experimental: Azithromycin
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
Intervention: Drug: Azithromycin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
November 2015
October 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01919996
A0661206
208291 ( Other Identifier: Alias Study Number )
2016-001119-19 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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