The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days
Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days
Bacteriologic success (Eradication: elimination of the original GABS; or Colonization: elimination of the original GABS but isolation of another stain of GABS) or failure (Persistence: presence of original GABS on repeated culture samples) rate
Time frame: Day 10
Bacteriological success or failure rate
Time frame: Day 30
Clinical success (resolution of signs and symptoms, or sufficient improvement; no additional antibacterial therapy indicated) or failure (insufficient improvement or worsening of signs and symptoms; additional antibacterial therapy indicated) rate
Time frame: Day 10
Clinical success or failure rate
Time frame: Day 30
Serious and non-serious adverse events (AEs) rates
Time frame: continuous
Rate of poststreptococcal complications and new disease occurrence since Day 10
Time frame: Day 30
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