A SHORT (3-DAY) COURSE OF AZITHROMYCIN TABLETS VERSUS A 10-DAY COURSEOF AMOXICILLIN-CLAVULANIC ACID (CO-AMOXICLAV) IN THE TREATMENT OF ADULTS WITH LOWER RESPIRATORY-TRACT INFECTIONS AND EFFECTS ON LONG-TERM OUTCOME

The efficacy and safety of a 3-day regimen of azithromycin prescribed in the new tablet form and of a 10-day regimen of amoxycillin-clavulan ic acid (co-amoxiclav, Augmentin(R)) were compared in patients with ac ute lower respiratory tract infections. Of the 144 enrolled patients, 123 had a Type 1 acute exacerbation of chronic bronchitis (AECB), thre e patients had pneumonia, and 18 had purulent bronchitis. Treatment wa s successful, defined as cure or major improvement on day 14, in 59/62 (95%) patients in the azithromycin treatment group compared with 54/6 1 (90%) patients in the co-amoxiclav. At 30 days, the incidence of suc cess was 77% (48/62) in the azithromycin treated group, compared with 66% (40/61) of co-amoxiclav-treated patients. At 60 days, incidences w ere 66% (41/62) and 59% (36/61); respectively. Several pathogens were isolated: Haemophilus influenzae in 21 patients (minimum inhibitory co ncentration (MIC) range for azithromycin 0.12-4 mg/l; co-amoxiclav 0.2 5-4 mg/l); Streptococcus pneumoniae in nine (MIC azithromycin less tha n or equal to 0.06 greater than or equal to 256 mg/l; co-amoxiclav les s than or equal to 0.06-1 mg/l); and Moraxella catarrhalis in 11 (MIC azithromycin less than or equal to 0.06-2 mg/l; co-amoxiclav less than or equal to 0.06-0.5 mg/l). Microbiological response rates were compa rable. A significant correlation between clinical and microbiological cure was found (p = 0.02, power 0.6). In 15 (10%) patients, positive s erology for viruses or atypical pathogens was found. In the co-amoxicl av-treatment group, 24 patients had mild adverse events (12 diarrhoea) , compared with 27 treated with azithromycin (p = 0.47). It is conclud ed that a 3-day regimen of azithromycin prescribed as tablets is as cl inically and microbiologically effective as a 10-day regimen of co-amo xiclav in the treatment of acute lower respiratory tract infections. M oreover, since the percentage of viral infections was low and a signif icant correlation between microbiological and clinical cure was found, this study shows that clinical symptoms car, be used to establish whi ch patients with AECB (Type 1) should be treated with antimicrobial ag ents. (C) 1998 Elsevier Science B.V.