Moxalactam: clinical summary of efficacy and safety.

The efficacy and safety of moxalactam disodium were studied by 173 investigators in the United States. Of 3,558 adult and pediatric patients who were treated for various infections, 2,234 met all protocol requirements for evaluation of efficacy of treatment. Effectiveness of moxalactam therapy was defined by a satisfactory bacteriologic response. The pooled data revealed that satisfactory responses were obtained in 80% of urinary tract infections, 91% of intraabdominal infections, 91% of obstetric and gynecologic infections, 92% of lower respiratory tract infections, 92% of skin and skin-structure infections, 90% of bone and joint infections, and 94% of bacteremic infections. The overall rate of efficacy of moxalactam therapy was 89%. The incidence of adverse reactions was low. Hypersensitivity occurred in 2.9% of the 3,558 patients, and gastrointestinal adverse effects, in 2.1%. No renal or hepatic toxicity was related to moxalactam therapy. Hypoprothrombinemia occurred in 25 patients, with clinically apparent bleeding in three. Alcohol intolerance was observed in four patients.