In a double-blind randomized study, amoxicillin-clavulanic acid (AM-CL) was compared with cefaclor for the treatment of acute urinary tract infections in 107 college women. A total of 53 patients received amoxicillin (250 mg) and clavulanic acid as the potassium salt (125 mg), and 54 received cefaclor (250 mg); each drug was administered every 8 h for 10 days. The cure rates at 1 and 4 weeks after treatment were 96 and 78%, respectively, in the AM-CL group and 92 and 75%, respectively, in the cefaclor group (P > 0.10). After AM-CL treatment, the prevalence of amoxicillin-resistant Eschenichia coli significantly increased in the rectal flora. Also, the frequency of bacterial resistance to amoxicillin, AM-CL, and cefaclor increased among the urinary pathogens causing subsequent urinary tract infections (P< 0.05). There were no adverse reactions in the cefaclor group; however, six patients in the AM-CL group (12%) experienced diarrhea, nausea, or vomiting (P< 0.05). Elevated transaminase enzyme levels were observed in 23% of the patients in the AM-CL group and in 6% of the patients in the cefaclor group (P< 0.05). Symptomatic Candida vaginitis developed in 16 and 13% of the patients in the AM-CL and cefaclor groups, respectively (P > 0.10).Bacterial resistance to the P-lactam antibiotics is largely due to the production of a ,-lactamase (1,5,20). Clavulanic acid inhibits many of these enzymes (16). A combination of amoxicillin (AM) and clavulanic acid (CL) is effective against a variety of ,-lactamase-positive bacteria (2, 4, 10, 12, 15). The purposes of this study were (i) to compare the efficacy and safety of AM-CL with the efficacy and safety of cefaclor in the treatment of acute urinary tract infections (UTIs) in young women, (ii) to relate therapeutic responses to the results of the antibody-coated bacteria test (ACBT), and (iii) to assess the emergence of resistant members of the Enterobacteriaceae in the rectal and urogenital areas after treatment.
MATERIALS AND METHODSPatient criteria. The study group consisted of college women who came to the Kidney Clinic of the University of Florida Student Health Services with symptoms of acute UTIs. The criteria for inclusion were as follows: (i) symptoms such as dysuria, urgency, and suprapubic or flank pain; (ii) at least one bacterium in each random high-power microscopic field of an unstained and uncentrifuged urine specimen; and (iii) 2105 CFU of a bacterium per ml in each of three consecutive urine specimens. Initially, 111 patients entered the study, but 4 had negative urine cultures and did not qualify, leaving 107 patients in the study. Excluded from the study were pregnant or lactating women and women with impaired renal or liver function, radiographically proven obstructive uropathy, or a history of allergy to penicillins or cephalosporins. Patients who had received antimicrobial agents during the preceding week were also excluded.Collection, processing, and analysis of specimens. A specially trained nurse instructed each patient to submit three * Correspond...