2, 3 Beyond providing a safe, welltolerated antibiotic regimen that is active against the most common community-acquired respiratory pathogens, one of the most attractive properties of both of these regimens is the inherent potential for enhancement of patient compliance.Īzithromycin has shown excellent activity against certain pathogens, such as Chlamydia spp., when it is administered as a single dose for extra-pulmonary infections. 1 Based on this research, this shorter regimen has been used successfully for a number of years in many countries throughout the world and is currently being evaluated for re-labelling in the United States. Significant research has been conducted in the past to support the use of a 3 day regimen (500 mg once daily for 3 days) of azithromycin rather than the currently utilized American 5 day regimen (500 mg day 1, 250 mg/day days 2–5). Owing to azithromycin's prolonged half-life of approximately 65 h, shorter and shorter dosage regimens are being studied for the treatment of community-acquired respiratory tract infections in both adults and children. These results suggest that a single oral 1.5 g regimen of azithromycin for respiratory tract infections should provide exposure at least equal to currently approved treatment regimens.
WBC results demonstrated much higher exposures than seen with serum, but no significant difference between the two regimens was identified. Serum data demonstrated no significant difference in exposure between the two regimens, although it favoured the shorter regimen. All subjects completed both regimens with minimal incidence of adverse effects. Statistics were via ANOVA with significance defined as P < 0.05. Data were modelled using noncompartmental methods. Serum samples were assayed via HPLC (CV% < 10) and WBC samples via liquid chromatography/mass spectrometry (CV% < 10). Serum and WBC samples were collected at baseline and repeatedly for 10 days following the first dose of each regimen. Twelve healthy volunteers received both azithromycin regimens (1.5 g single dose and 500 mg/day for 3 days) in random order. Equal exposures would help validate future clinical trials of single dose regimens.
The goal of the present study was to investigate whether there were equal serum and WBC exposures when azithromycin was dosed as the current 3 day regimen or as a single large dose. Similar trials are currently underway in both adult and paediatric populations. An earlier clinical study using the entire 1.5 g dose at once or the current 3 day regimen in patients with atypical pneumonia noted equal efficacy. Previous studies have concluded that the 3 and 5 day (1.5 g total) regimens not only provide at least equal serum and WBC exposures but also equal efficacy rates. Owing to azithromycin's prolonged half-life, shorter and shorter dosage regimens are being studied for treatment of respiratory tract infections.
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