Multicenter trials were conducted to determine the safety and efficacy of
aztreonam in the treatment of patients with
gram-negative bacterial infections. A total of 2,821 patients were treated; 2,117 received
aztreonam and 704 received control
antibiotics. All patients were evaluated for safety and 1,180 of those treated with
aztreonam and 428 treated with the control drugs met the criteria for efficacy evaluation. The number of patients treated with
aztreonam who were evaluable for efficacy and their microbiologic response rates were:
urinary tract infections, 443 (82 percent); lower
respiratory tract infections, 217 (79 percent);
septicemia, 63 (98 percent); skin/skin structure
infections, 136 (88 percent);
intra-abdominal infections, 47 (85 percent); postpartum/gynecologic
infections, 21 (100 percent); bone and joint
infections, 12 (100 percent); acute uncomplicated
gonorrhea, 209 (97 percent); and acute uncomplicated
cystitis, 56 (84 percent). Adverse reactions were qualitatively similar to those reported for
beta-lactam antibiotics, i.e., mild gastrointestinal upset,
rash,
eosinophilia, or transient increase in hepatic
enzyme parameters. There was an apparent lack of adverse effects on kidney, inner ear, and blood coagulation system. The most frequent adverse effect was
phlebitis at infusion site (2.4 percent of patients).
Superinfections and colonization with new organisms occurred in 9.4 percent of
aztreonam-treated patients and in 7.4 percent of control drug-treated patients; only 40 percent of patients in each group, approximately 4 percent of all patients receiving
aztreonam and 3 percent of those receiving control
antibiotics, required specific
therapy for the
superinfection. Overall, results indicated that
aztreonam is a safe and effective
antibiotic in the treatment of aerobic gram-negative
infections, when used either as monotherapy or in combination with other
antibiotics.