Results of noncomparative studies of cefotetan in the treatment of obstetric and gynecologic infections.

In a multicenter trial involving 11 centers, 160 women were enrolled to evaluate the safety and effectiveness of 1 or 2 gm of cefotetan administered every 12 hours in the treatment of obstetric and gynecologic infections. The 133 evaluable patients generally were under 25 years of age, were nonwhite, and had hospital-acquired endometritis or pelvic inflammatory disease caused by both aerobic and anaerobic bacteria. Escherichia coli, Neisseria gonorrhoeae, group D streptococci, Bacteroides sp., and Peptococcus sp. were among the most frequently isolated pathogens. The patients were treated for a mean of 5.6 +/- 1.6 days and received a total dose of 19.27 gm. The signs and symptoms of infection were cleared or improved in 93% of the 133 patients evaluable for clinical response. Of the 116 evaluated bacteriologically, 95% had a satisfactory or presumed satisfactory response; only six patients (5%) were considered to be bacteriologic failures. Differences in the results of several clinical laboratory tests performed before and after treatment were statistically, but not clinically, significant (p less than 0.05). Safety was evaluated in the 158 patients who received cefotetan, and only four (3%) had adverse reactions considered related to the drug. Cefotetan was clearly effective and produced no untoward reactions in these women with obstetric and gynecologic infections caused by both aerobic and anaerobic organisms when administered at 1 or 2 gm every 12 hours.