A multi-centre general practice comparison of a fixed-dose combination of pivmecillinam plus pivampicillin with amoxycillin in respiratory tract infections.

Seven-day courses of either 200 mg pivmecillinam plus 250 mg pivampicillin given twice daily or 250 mg amoxycillin given 3-times daily were compared in a multi-centre general practice study in 350 patients with symptoms of upper or lower respiratory tract infection. Patients were stratified into four diagnostic groups: sinusitis, otitis media, throat infections, and acute bronchitis, and randomly allocated to treatment within these groups. Assessments at 7 days showed no difference in overall clinical efficacy between the two treatments; however, patients with acute bronchitis showed a better response to pivmecillinam plus pivampicillin. After treatment, signs of infection were absent in 139 (79%) patients in the pivmecillinam plus pivampicillin group and in 143 (80%) patients in the amoxycillin group. Both treatments were well tolerated, adverse effects being reported in only 17 (9.8%) patients after pivmecillinam plus pivampicillin and 15 (8.6%) patients after amoxycillin. These were mainly associated with disturbances of the gastro-intestinal tract where reports of diarrhoea were twice as common after amoxycillin.