Study to Evaluate the Potential of Azithromycin to Cause Eye Problems in Childre

• Conditions: pharyngitis/tonsillitis; MedDRA version: 19.0Level: PTClassification code 10034835Term: PharyngitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: PTClassification code 10044008Term: TonsillitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2016-001119-19-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-13
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Generally healthy male or female subject, aged 12 to 17 years, who required outpatient treatment for an acute pharyngitis/tonsillitis infection that was appropriate to treat with oral azithromycin.
2. Subjects must have had a positive rapid antigen detection test (RADT) at baseline.
3. Subject was sighted in both eyes and has no known history of any clinically significant eye disease or condition, apart from a need for corrective lenses.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with known hypersensitivity to azithromycin, erythromycin, or any macrolide or ketolide antibiotic.
2. Subjects who had taken another antibiotic within the previous 3 days, or had taken azithromycin (any formulation, including sustained release) within the past 4 weeks.
3. Subjects with clinical evidence or current/past history of: impaired hepatic or renal function; clinically significant congenital or acquired cardiac disease including cardiac rhythm disorders; myasthenia gravis or other significant neuromuscular disorder; or any other disease or condition that could have put the subject at increased risk for injury if he/she participated in the study.
4. Subjects with increased risk of QT prolongation, including known personal or family history of prolonged QT syndrome, serious ventricular arrhythmia or family history of sudden cardiac death; subjects currently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classes IA and III and antipsychotic agents, antidepressants and fluoroquinolones; subjects with electrolyte disturbance, particularly in cases of hypokalemia and hypomagnesemia; subjects with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
5. Subjects with chronic diseases of the gastrointestinal tract which might have either adversely affected absorption of the drug and/or put the subject at increased risk for injury in the event antibiotic associated diarrhea or similar illness occurred.
6. Subjects with a medical condition at baseline that required concomitant treatment with a drug known to have effects on vision (ie, a drug whose package insert reported pharmacologic effects on the eye or contained any specific warning of possible adverse effects on the eye or vision based on clinical study results).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified