Efficacy of spiramycin as an alternative to amoxicillin in the treatment of acute upper respiratory tract infections.

This study compared the efficacy of spiramycin with that of amoxicillin in treating patients with acute community-acquired upper respiratory tract infections (URTIs). The study was an open, randomised, comparative parallel design and patients received either spiramycin 3 MIU (2 tablets, 500mg or 1.5 MIU per tablet) twice daily after meals, i.e. 6 MIU/day for 7 days or amoxicillin (500 mg/capsule) 1 capsule three times daily after meals, i.e. 1500 mg/day for 7 days. Patients attending the ENT outpatient clinic at Siriraj Hospital in Bangkok for treatment of acute URTIs were included in the study after giving their informed consent. Eligible patients comprised those aged 18 years and over, of either gender, who had at least two of the following symptoms: fever (>/=38 degrees C oral), nasal discharge/obstruction, sore throat, cough and/or hoarseness of voice that did not require parenteral drug therapy or hospitalisation. A total of 99 patients were included in this study, 49 patients received spiramycin and 50 received amoxicillin. Of the 45 assessed patients treated with spiramycin, 40 were judged by the investigators as a 'success' (89%), and five were judged a 'non-success' (11%), compared with 48 assessed patients in the amoxicillin group where 40 patients were classified as a 'success' (83.3%) and 8 were judged a 'non-success' (16.7%). No statistically significant differences between treatments were demonstrated regarding the overall efficacy of treatment. This study demonstrated that the prescribed regimens of spiramycin and amoxicillin were similarly effective in the treatment of adult acute URTIs. The tolerability of both drugs was also similar. Furthermore, it was noted that the convenient twice-daily dosage regimen of spiramycin may allow better patient compliance.

RCT Entities:   Population Interventions Outcomes