Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection
Japanese Journal of Antibiotics 50(6): 535-577
1997
ISSN/ISBN: 0368-2781 PMID: 9258742 Document Number: 476225
The third edition of the Criteria for Evaluation of Clinical Efficacy of Antimicrobial Agents on Urinary Tract Infection (UTI Criteria Third Edition, 1986) established criteria which have been widely used to evaluate the clinical efficacy of antimicrobial agents on uncomplicated and complicated urinary tract infection (UTI). Thereafter, criteria on urethritis and prostatitis were prepared by the UTI Committee and published as the supplements to the UTI Criteria Third Edition. In keeping with the establishment of IDSA/FDA Guidelines in the US, and realizing the importance of having an international harmonization upon method to evaluate the clinical efficacy of antimicrobial agents on UTI, a subcommittee (consisted of members shown below) of the Clinical Evaluation Guidelines Committee of the Japan Society of Chemotherapy has drafted guidelines of the revised criteria for acute uncomplicated cystitis and complicated UTI. Those drafts have also been reviewed by the UTI Committee. The criteria were revised keeping the following three basic considerations in mind. 1. Adhere to the previous UTI Criteria as much as possible so that it will still be possible to compare the results of new studies with those obtained under the previous UTI Criteria. 2. Keep the revised criteria consistent with the already established and published IDSA/FDA Guidelines and European Guidelines. 3. The draft criteria are provisional due to the problems which exist in fixing final standards at this time. The final standard criteria will be made after accumulating data on patients evaluated in accordance with the draft criteria and reviewing the results after several years. Therefore, the current draft was designed so the content can be easily reevaluated; e.g. a wide range of criteria for the selection of patients so that the clinical data can be investigated by stratification. The revised criteria are effective from January, 1997, and all of the clinical studies conducted thereafter are requested to conform the criteria.