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Table 1.Distribution and number of cases with acute upper respiratory tract infections classified according to antimicrobial agents administered

Table 2. Distribution of cases which were enrolled to set up new diagnostic criteria of acute upper respiratory tract infections a) 2,257 cases selected by investigators b) 1,172 cases in which 5 laboratory examinations were performed New inclusion criteria require five laboratory examinations, i.e., microbiological study, white blood cell counts, stab count, C-reactive protein level and body temperature for the evaluation of new antimicrobial agents. Table 3. Comparison of the severity of the disease as judged by the investigator with that according to the new criteria a) Pharyngitis (170 cases) b) Tonsillitis (651 cases) * conformity rate: 45.2 % c) Bronchitis (697 cases)

Acute pharyngitis Body temperature White blood cell C-reactive protein Severity of infection Acute tonsillitis Body temperature White blood cell C-reactive protein Acute bronchitis Body temperature C-reactive protein Fig. 1. Distribution of body temperature, white blood cell counts and CRP levels in cases with acute pharyngitis (a), acute tonsillitis (b) or acute bronchitis (c) which received oral or parenteral antimicrobials classified by severity as judged by the investigators. Results are mean } 1 Ý. Data obtained from groups with less than 5 cases are not shown. Columns (,ƒ, ) indicate disease severity (mild, moderate and severe). Numbers in parenthesis under the number of cases which received oral or parenteral antimicrobials indicate the number of cases divided into the three degrees of severity (mild, moderate and severe).

Table 4. Distribution of cases in which clinical effectiveness assessed by investigators (A) was in agreement with that according to new criteria (B) a) 155 cases which fulfilled new inclusion criteria b) 79 cases which did not fulfill new inclusion criteria

DEC. 1998 Beam T R Jr., Gilbert D N, Kunin C M: General guidelines for the chinical evaluation of anti-infective drug products. Clin. Infect. Dis. 15 (Suppl. 1): S 5 `32, 1992 European Society of Clinical Microbiology and Infectious Disease: European guidelines for the clinical evaluation of anti-infective drug products 1993 Chow A W, Hall C B, Klein J 0, et al.: General guidelines for the evaluation of new anti-infective drugs for the treatment of respiratory tract infections. Clin. Infect. Dis. 15 (Suppl. 1): S 62 `88, 1992

Studies on general guidelines for the evaluation of new antimicrobial agents for the treatment of respiratory tract infections respiratory tract Akira Watanabe, Fumio Miki, Kotaro Ohizumi, Naoto Rikitomi, Hironobu Koga, Yoshihito Niki, Nobuchika Kusano and Atsushi Saito Committee for the Chinical Guidelines of New Antimicrobial Agents for the Treatment of Respirarory Tract Infections, Japan Society of Chemotherapy, 2-20-8 Kamiosaki, Shinagawa-ku, Tokyo 141-0021, Japan "General guidelines for the evaluation of the new antimicrobial agents for the treatment of res - piratory tract infections" was reported by our committee in the Japanese Journal of Chemotherapy ("General Guidelines" Vol. 45: 762 `778, 1997). The aim of the present paper is to discuss the validity of the above "General Guidelines", when applied for the study of the cases with acute upper respiratory tract infections (AURTI), and, if necessary, to set up a new guideline of the therapeutics of AURTI. For this purpose, a total of 2,257 cases with acute pharyngitis, acute tonsillitis or with acute bronchitis, which had been enlisted for the phase II and phase III clinical studies of new antimicrobials in Japan, were enrolled in the present study.most of them were selected and enrolled on the basis of the judgement by investigators, and 1,518 cases (67%) were found to fulfil the criteria of "General Guidelines". All of the 5 different measurements recommended by the ad hoc committee (microbial study, WBC counts, stab count, CRP level and body temperature) were done only in 1,172 enrolled cases, and 947 cases (81%) were found to fulfil the new diagnostic criteria. The degree of the severity of the disease judged by investigators differed somewhat each other between the per os medication cases and the parenteral medication cases, and the number of moderate cases was the largest.however, the number of mild cases was the largest according to the "General Guidelines". Of 1,518 cases which fulfilled the new criteria, the ratio of mild/moderate/severe cases by the judgement of investigators was 41/50/9 and that by the new criteria was 50/39/11. The ad hoc committee stated that laboratory examinations at the 7 th day after initiation of chemotherapy were "a must" for the correct evaluation of the effectiveness of antimicrobials administered. However, laboratory examinations at the 7 th day were done only in 234 cases, the judgemnt by investigators was comparable to that by the committee in 203 of 234 cases (87%). As a conclusion, the new guideline set up by the ad hoc committee is appropriate for the diagnosis, evaluation of severity of diseases, and for the evaluation of the effectiveness of antimicrobial agents used for the treatment of AURTI.

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