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A short (3-day) course of azithromycin tablets versus a 10-day course of amoxycillin-clavulanic acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects on long-term outcome

Hoepelman IM, Möllers MJ, van Schie MH, Greefhorst AP, Schlösser NJ, Sinninghe Damsté EJ, van de Moosdijk CN, Dalinghaus WH et al.

International journal of antimicrobial agents, 1997

144 participants

Abstract

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 clavulanic acid (co-amoxiclav, Augmentin) were compared in patients with acute lower respiratory tract infections. Of the 144 enrolled patients, 123 had a Type 1 acute exacerbation of chronic bronchitis (AECB), three patients had pneumonia, and 18 had purulent bronchitis. Treatment was successful, defined as cure or major improvement on day 14, in 59/62 (95%) patients in the azithromycin treatment group compared with 54/61 (90%) patients in the co-amoxiclav. At 30 days, the incidence of success was 77% (48/62) in the azithromycin treated group, compared with 66% (40/61) of co-amoxiclav-treated patients. At 60 days, incidences were 66% (41/62) and 59% (36/61), respectively. Several pathogens were isolated: Haemophilus influenzae in 21 patients (minimum inhibitory concentration (MIC) range for azithromycin 0.12-4 mg/l; co-amoxiclav 0.25-4 mg/l); Streptococcus pneumoniae in nine (MIC azithromycin or = 256 mg/l; co-amoxiclav < or = 0.06-1 mg/l); and Moraxella catarrhalis in 11 (MIC azithromycin < or =0.06-2 mg/l; co-amoxiclav < or = 0.06-0.5 mg/l). Microbiological response rates were comparable. A significant correlation between clinical and microbiological cure was found (p = 0.02, power 0.6). In 15 (10%) patients, positive serology for viruses or atypical pathogens was found. In the co-amoxiclav-treatment group, 24 patients had mild adverse events…

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 144 participants or records.

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