Sultamicillin experiences in the field of internal medicine.

Sultamicillin is a substance in which sulbactam, a beta-lactamase inhibitor, is covalently linked through an ester group to ampicillin. This paper describes the results of a clinical trial with sultamicillin in the infectious diseases encountered in internal medicine. In an open segment of the trial, 426 adult patients were treated orally with sultamicillin. The efficacy rates achieved were 86.1% (136/158) in acute respiratory infections, 67.5% (137/203) in chronic respiratory infections, 92.9% (39/42) in acute urinary tract infections, 76.9% (10/13) in chronic urinary tract infections, and 70.0% (7/10) in other types of infections. The bacteriological efficacy of sultamicillin was 83.8% (62/74) for Gram-positive and 74.0% (159/215) for Gram-negative bacteria. Efficacy was similar, 81% (17/21), for those strains that were high producers of beta-lactamase. Adverse reactions were observed in 10.1% of the patients in the open phase of the trial. In the double-blind segment, sultamicillin was compared with bacampicillin in respiratory infections, including pneumonia, lung abscesses, and chronic respiratory tract infections. One tablet of either drug was given orally three times a day for 14 d. Evaluation of clinical effectiveness by the trial committee revealed efficacy rates of 82.8% (96/116) for sultamicillin and 69.8% (81/116) for bacampicillin, indicating a significant superiority for sultamicillin. All of this difference resulted from the superior efficacy of sultamicillin (89.2%) over that of bacampicillin (63.2%) in patients with chronic respiratory infections. Efficacy in pneumonia was the same for both agents. Adverse reactions to sultamicillin and bacampicillin were observed in 16.3% (21/129) and 6.3% (8/127) of the cases, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes