Experience with the new guidelines on evaluation of new anti-infective drugs for the treatment of urinary tract infections.

The new guidelines of Infectious Diseases Society of America (IDSA) and European guidelines of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) on evaluation of new anti-infective drugs for the treatment of urinary tract infection (UTI) were published in 1992 and 1993, respectively. The experience with these guidelines, including the recommendations for improvement published by an international expert group, are being updated and discussed. The IDSA and ESCMID guidelines define five categories of UTI. Some aspects specific for each group are discussed concerning definition, stratification and outcome. For patients with chronic bacterial prostatitis, a category of its own is proposed rather than using the general category of complicated UTI. The greatest advantage of the new guidelines in comparison with the former FDA guidelines is enrolment of patients according to intention to treat, as has always been recommended by the guidelines of the Japanese UTI Committee. Two problems arising in studies of all categories are addressed: (i) false positive bacteriuria and (ii) handling of dropouts and missing data. Compared with the former FDA guidelines, the new IDSA and ESCMID guidelines reflect much better the clinical situation of the physician taking care of individual patients. Therefore, the results of studies performed according to these guidelines are clinically more significant. A worldwide harmonization of guidelines may finally lead to valid and acceptable results in any country.