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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Martel Eye Medical Group
Rancho Cordova, California, 95670 United States
Contact
1-800-718-1021
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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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