Efficacy and safety of azithromycin in the treatment of pediatric upper respiratory tract infections, an open non-comparative multicentre study.

ABSTRACT

The clinical efficacy and safety of a three-day course of azithromycin was evaluated in 39 children (aged 1-15 years) with clinical diagnosis of acute upper respiratory tract infections (acute pharyngitis and/or acute tonsillitis, acute otitis media and acute sinusitis). Patients received azithromycin in a single daily dose of 10 mg/kg (maximum 500 mg) orally for three days. Clinical assessment and throat culture were carried out before and after therapy. Overall clinical efficacy was fund to be satisfactory (cured or improved) in 37/39 (94.8 percent) of patients. Bacteriological efficacy, which was evaluated by eradication of the pathogens, was found in 16/18 (88.8 percent). In the remaining two patients, one was clinically cured despite persistent Staphylococcus aureus, while the other case of clinical failure was associated with a resistant strain of Psuedomonas seruginosa. The drug was well tolerated and treatment-related side-effects, which were reported in only 3*39 (7.69 percent) of the patients, were gastrointestinal in nature and of mild severity. The results of the study indicated that a single daily dose, in a three-day regimen, of azithromycin is effective and well-tolerated in the treatment of children with acute upper respiratory tract infections.