Double-blind comparison of pivmecillinam plus pivampicillin ('Miraxid') with pivampicillin alone in chronic bronchitis: a Danish multi-centre study.

A double-blind, multi-centre trial was carried out in 62 patients with purulent exacerbations of chronic bronchitis to compare the efficacy and tolerance of pivmecillinam plus pivampicillin with that of pivampicillin given alone. Patients were allocated at random to receive treatment with either 100 mg pivmecillinam plus 125 mg pivampicillin or 250 mg pivampicillin 3-times daily for 7 to 14 days. A satisfactory clinical response was observed in 28 (88%) out of the 32 patients given pivmecillinam/pivampicillin. Twenty-two (73%) out of the 30 subjects taking pivampicillin alone responded to therapy. Combination therapy appeared to be more effective in rendering purulent sputum mucoid. After treatment was completed, fewer pathogens including pneumococci, Haemophilus influenzae and Enterobacteriaceae were present in the sputum of patients given the combination (4 out of 14 cases) when compared to subjects who took pivampicillin alone (10 out of 15 cases). Both treatments were well tolerated. One patient taking pivmecillinam/pivampicillin and 5 subjects given pivampicillin reported mild gastro-intestinal discomfort.

RCT Entities:   Population Interventions Outcomes