A randomized, phase II, dose-ranging trial of metampicillin/sulbactam (Mepicin) in the treatment of acute pyelonephritis

Sohn, J W; Kim, C H; Park, O; Cheong, H J; Kim, W J; Kim, M J; Park, S C; Kim, S I; Kim, Y K

Abstract

Background
Mepicin is new product comprised of metampicillin; broad spectrum penicillin and sulbactam; beta-lactamase inhibitor. The purpose of this study was to determine the efficacy, safety, and appropriate dosage of Mepicin in patients with acute pyelonephritis.
METHODS
We randomly assigned ninety-two hospitalized adult patients with acute pyelonephritis, aged between 20 and 70 years old, into the three groups according to the three different dosages of the Mepcin initially, but excluded 32 patients later because their urine culture were negative. The rest 60 patients were divided into the three groups: 3 g/day (group 1, n=20), 4.5 g/day (group 2, n=20), and 6 g/day (group 3, n=20) of Mepicin. These groups received the Mepcin intravenously for 7 to 10 days. Clinical and bacteriological responses were evaluated during the treatment. We followed the patients daily for the clinical response with periodic laboratory evaluation.
RESULTS
Efficacy and safety shows no significant differences among three groups. Overall clinical response rate of all three groups was 93.3% (56/60). There were three relapses (5%) and one treatment failure (1%). The bacteriological eradication rate was 88.3% (53/60) regardless of the dosages. Most commonly isolated organism was E. coli (98%). Adverse drug reactions of Mepcin were as follows: eosinophilia (33.3%), abnormal liver function (15%), leukopenia (6.7%), urticaria (1.6%), rash (1.6%), increased BUN (1.6%), and total bilirubin (1.6%). All adverse reactions subsided without any specific treatment, except one patient who had urticaria that was subsided with antihistamine.
Conclusions
This study suggest that Mepicin is effective and safe in the treatment of acute pyelonephritis among all 3 groups. Therefore we recommend 3 gram of Mepcin per day for the patient with acute pyelonephritis since there were no significant differences in effectiveness of the treatment among different dosage groups and also considering cost-effectiveness.