SULBACTAM IN COMBINATION WITH MEZLOCILLIN, PIPERACILLIN OR CEFOTAXIME- CLINICAL AND BACTERIOLOGICAL FINDINGS IN THE TREATMENT OF SERIOUS BACTERIAL-INFECTIONS (REPRINTED FROM MED KLIN, VOL 86, PG 454, 1991)

An open, multicentre study was performed in hospital in-patients at a total of 12 German hospitals to investigate the efficacy and tolerabil ity of sulbactam combined with mezlocillin, piperacillin or cefotaxime in severe bacterial infections, A total of 155 patients were recruite d into the study, of whom 48 were suffering from respiratory tract inf ections, 66 from intra-abdominal infections, 34 from skin/soft tissue infections including postoperative wound infections, and five from com plicated urinary tract infections. Fifty-five patients intravenously r eceived 4 g mezlocillin and 1 g sulbactam three times daily, 52 receiv ed 4 g piperacillin and 1 g sulbactam three times daily, and 48 receiv ed 2 g cefotaxime and 1 g sulbactam three times daily. The antibiotic and sulbactam combination was administered in all cases by rapid intra venous infusion of both components together, over 20 min. The mean dur ation of treatment was 20 days. The criteria used to define the outcom e of treatment as successful were clinical cure (complete disappearanc e of the signs and symptoms of infection seen before the start of trea tment) or improvement (appreciable diminution or partial resolution of the initial signs and symptoms, no further antibiotic therapy require d) and the elimination of the organisms isolated before the start of t he study. Of the 153 clinically evaluable patient, 141 (92%) were clas sed as responders (a cure was obtained in 98 cases and improvement in 43 cases). No response to the study medication was seen in 12 patients (7.8%). The response rates of the combined antibiotic-sulbactam prepa rations were 91% for mezlocillin/sulbactam, 92% for piperacillin/sulba ctam, and 93% for cefotaxime/sulbactam. These response rates are almos t identical. A total of 106 patients (68.4%) were bacteriologically ev aluable; a total of 192 bacterial organisms were identified in these p atients before the start of treatment. Mixed infection was present in 55 patients, The causative organism initially isolated was eliminated in 96 patients (90%), accounting for 180 of 192 strains (94%). Persist ence of the causative organism (12 strains) was seen in eight patients (7.6%). Superinfection (four strains) was seen in two patients (1.9%) . The study medication was well tolerated; adverse drug effects were s een in only five patients (3.3%). Treatment was discontinued in one pa tient because of the adverse effect (exanthema). The combination of th e beta-lactamase inhibitor sulbactam and a ureidopenicillin or cefotax ime was highly efficacious in patients with severe bacterial infection s investigated in this study. The availability of sulbactam as a singl e-agent preparation opens up new avenues for flexible and cost-effecti ve antibiotic therapy and is a valuable contribution to the control of bacterial resistance.