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

NCT01919996

Last updated date
Study Location
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Contact
1-800-718-1021

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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.

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Pharyngitis, TonsillitisPASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
NCT01919996
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  2. Chicago, Illinois
  3. Chicago, Illinois
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  5. Murray, Utah
  6. Salt Lake City, Utah
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12 Years+
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Advanced Information
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
  • Pharyngitis
  • Tonsillitis
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
 (submitted: December 7, 2015)
8
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2013)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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