Efficacy of penicillin treatment in purulent maxillary sinusitis. A European multicenter trial.

Three hundred and one patients with maxillary sinusitis participated in a double-blind, randomized study at 11 ENT-clinics in Europe. Sinusitis was diagnosed by the presence of at least two signs and symptoms and sinus X-ray showing more than 6 mm swelling of the maxillary mucosa. A microbiological specimen was obtained by intrasinusal aspiration. The patients were randomly assigned to treatment either with bacampillin 800 mg b. i. d. or with amoxicillin 500 mg t. i. d. for ten days. The most frequently isolated bacteria were Haemophilus influenzae (94 strains), Streptococcus pneumoniae (66 strains) and Branhamella catarrhalis (12 strains). In 96 of the patients, no microorganisms could be isolated. Beta-lactamase production was found in one H. influenzae strain and in three B. catarrhalis strains. Two hundred and seventy-one patients could be evaluated for efficacy at the follow-up visit day 8-25. The overall clinical outcome was the same in both treatment groups. Adverse events such as skin reactions and upper and lower gastrointestinal reactions occurred in 17.4% of the amoxicillin treated patients and in 10.8% of the bacampicillin treated patients (p = 0.101).

RCT Entities:   Population Interventions Outcomes