title: Sulbactam in combination with mezlocillin, piperacillin or cefotaxime: clinical and bacteriological findings in the treatment of serious bacterial infections.
abstract: An open, multicentre study was performed in hospital in-patients at a total of 12 German hospitals to investigate the efficacy and tolerability of sulbactam combined with mezlocillin, piperacillin or cefotaxime in severe bacterial infections. A total of 155 patients were recruited into the study, of whom 48 were suffering from respiratory tract infections, 66 from intra-abdominal infections, 34 from skin/soft tissue infections including postoperative wound infections, and five from complicated urinary tract infections. Fifty-five patients intravenously received 4 g mezlocillin and 1 g sulbactam three times daily, 52 received 4 g piperacillin and 1 g sulbactam three times daily, and 48 received 2 g cefotaxime and 1 g sulbactam three times daily. The antibiotic and sulbactam combination was administered in all cases by rapid intravenous infusion of both components together, over 20 min. The mean duration of treatment was 20 days. The criteria used to define the outcome of treatment as successful were clinical cure (complete disappearance of the signs and symptoms of infection seen before the start of treatment) or improvement (appreciable diminution or partial resolution of the initial signs and symptoms, no further antibiotic therapy required) and the elimination of the organisms isolated before the start of the study. Of the 153 clinically evaluable patient, 141 (92%) were classed 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 preparations were 91% for mezlocillin/sulbactam, 92% for piperacillin/sulbactam, and 93% for cefotaxime/sulbactam. These response rates are almost identical. A total of 106 patients (68.4%) were bacteriologically evaluable; a total of 192 bacterial organisms were identified in these patients 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%). Persistence 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 seen in only five patients (3.3%). Treatment was discontinued in one patient because of the adverse effect (exanthema). The combination of the beta-lactamase inhibitor sulbactam and a ureidopenicillin or cefotaxime was highly effiacious in patients with severe bacterial infections investigated in this study. The availability of sulbactam as a single-agent preparation opens up new avenues for flexible and cost-effective antibiotic therapy and is a valuable contribution to the control of bacterial resistance.
authors.affiliation: Chirurgische Universitätsklinik Tübingen, Hoppe-Seyler-Strasse 3, D-72076 Tübingen, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Manncke
authors.forename: M
authors.initials: M
authors.lastname: Springsklee
authors.forename: W R
authors.initials: WR
authors.lastname: Heizmann
authors.forename: H G
authors.initials: HG
authors.lastname: Sonntag