Abstract
In an open, prospective clinical trial, we evaluated the safety and efficacy of apalcillin in the treatment of complicated urinary tract infection. 21 hospitalized adult patients received apalcillin 2 g IV Q8-12h for 5–17 days. There were 8 upper tract and 13 lower tract infections. Of 25 functional or anatomic abnormalities of the GU tract among these patients, 9 (36%) were corrected during the study period. Effectiveness of apalcillin was determined by clinical and bacteriologic response. 16 (76.2%) patients had clinical cures, 4 (19.8%) had clinical improvement, and 1 (4.8%) had clinical failure. Based on 26 pretreatment isolates, there were 16 (61.5%) bacteriologic cures and 10 (38.5%) failures. Failures were due to 6 (23.1 %) relapses, 2 (7.7%) superinfections, and 2 (7.7%) relapses with superinfection. Adverse reactions were mild, transient, and did not require discontinuation of treatment. Apalcillin appears to be a safe, although marginally effective single agent antibiotic for the treatment of complicated urinary tract infections.