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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 2

Conditions

Tonsillitis
Pharyngitis

Treatments

Drug: Azithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01919996
2016-001119-19 (EudraCT Number)
208291 (Other Identifier)
A0661206

Details and patient eligibility

About

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).

Full 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.

Enrollment

8 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Azithromycin
Experimental group
Description:
Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
Treatment:
Drug: Azithromycin

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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