EUCTR2016-001119-19-Outside-EU/EEAActive, not recruitingNot Applicable
Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/tonsillitis
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Pfizer Inc.
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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).
Investigators
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