AMPICILLIN PLUS MECILLINAM VS CEFOTAXIME CEFADROXIL TREATMENT OF PATIENTS WITH SEVERE PNEUMONIA OR PYELONEPHRITIS - A DOUBLE-BLIND MULTICENTER STUDY EVALUATED BY INTENTION-TO-TREAT ANALYSIS/

In this double-blind multicentre study, using the intention-to-treat a pproach, a total of 293 patients with fever (greater than or equal to 38.5 degrees C), symptoms of sepsis and signs of pneumonia or pyelonep hritis were randomly assigned to treatment with ampicillin and mecilli nam (A + M) or cefotaxime followed by cefadroxil. In the febrile phase , treatment was given intravenously twice daily, either with 1,200 mg ampicillin together with 600 mg mecillinam or with 2 g cefotaxime alon e. When the patients stayed afebrile, the intravenous administration w as replaced by oral treatment twice daily for 14 days, either with 500 mg pivampicillin and 400 mg pivmecillinam or 1 g cefadroxril. In the A + M group, 33% (48/144) of the patients did not complete the full co urse of treatment as compared with 32% (47/149) in the cephalosporin g roup, the reasons being treatment failure in 27 and 29, respectively, or adverse effects (n = 16 in both groups), The median duration of fev er was 47 h in the A + M group and 50 h in the cephalosporin group. Of 135 patients with pneumonia, 68% were completely cured in the A + M g roup, and 65% in the cephalosporin group, the main reasons for treatme nt failure being Mycoplasma pneumonia or ornithosis. Of 136 patients w ith pyelonephritis, 63% were cured in each group. The main reason for failure was bacteriological relapse. Side-effects were reported by 32 patients (22%) of the A + M group, as compared with 41 (28%) of the ce phalosporin group. Epigastric complaints were equally frequent in both groups, but there was a tendency for a higher frequency of exanthema in the A + M group, and for antibiotic-associated diarrhoea and fungal superinfections in the cephalosporin group.