Clinical evaluation of DQ-2556, a new parenteral cephem antibiotic, and a dose-determination study in complicated urinary tract infections

Sadao Kamidono, Soichi Arakawa, Masuo Yamashita, Shinsuke Takagi, Hideo Oshima, Nobuo Kataoka, Ichiro Nakamura, Takehiro Izumi, Yuji Yamada, Masayuki Sugimoto, Minoru Hazama, Atsushi Sengoku, Yoshiaki Kumamoto, Takaoki Hirose, Yasuhiro Yamaguchi, Yoshikazu Sato, Yoshio Aso, Masaya Oshi, Hiroshi Nito, Nobuo KawamuraHiroaki Inatsuchi, Keishi Okada, Hideaki Hoshino, Motoaki Tanaka, Keizo Suzuki, Yukimichi Kawada, Yoshihito Ban, Yoshito Takahashi, Kanhin Tei, Akihisa Takeda, Hiroyuki Ohmori, Hiromi Kumon, Kazuhiro Hata, Daisuke Yamada, Katsuichi Nanba, Nishitani Mitsuhata Naoki, Joichi Kumazawa, Tetsuro Matsumoto, Noritsugu Shi, Takashi Yoshida, Mitsuru Noguchi, Tetsunori Nakayama, Kazuyuki Sagiyama, Kiyoshi Komatsu, Sanshin Hara, Kenji Itoh, Tetsuo Omoto, Yasuhiro Koikawa, Ken Goto, Takeo Kurozumi, Tetsuo Omoto, Yoshitada Ohi, Motoshi Kawahara, Daishi Yamauchi, Takeshi Shimada, Shinichi Nagata, Tsuneyoshi Kayajima, Akira Imamura, Shizuo Yagi, Nobuya Ogawa, Koichi Deguchi, Nobumasa Kataoka

Research output: Contribution to journalArticle

Abstract

To evaluate the effectiveness and the safety of DQ-2556, a new parenteral cephem antibiotic, and to find its optimal dose in the treatment of complicated urinary tract infections (UTI) multicenter clinical trials were conducted. Data were summarized according to the criteria of the Japanease UTI committee (the third edition). 1) Open clinical trials DQ-2556 was administered mainly at doses of 0.5g, l.Og and 2.0g twice a day. In the 80 evaluable patients, 32 had excellent, 24 moderate and 24 poor results; the overall efficacy rate was 70.0%. Twice-a-day medication was dose-dependently effective (moderate or excellent):efficacy rates for treatment at doses of 0.5 g b.i.d., 0.g b.i.d. and 2.0g b.i.d. were 59.1% in 22 patients, 73.0% in 37 patients and 80.0% in 10 patients. DQ-2556 was effective in 77.8% of 54 non-indwelling -catheter patients and in 53.8% of 26 indwelling-catheter patients. The overall bacteriological eradication rate was 82.2% (106/129);40 at 49 m-positive bacteria (81.6%) and 66 of 80 gram-negative bacteria (82.5%) were eradicated. Clinical adverse reactions were observed in three in 116 patients (2.6%): a patient vomited severely with nausea three days after the commencement of treatment and another showed mild to moderate eruption. Laboratory adverse reactions were seen in 14 in 109 patients (12.8%); the main findings were abnormalities of liver function represented by elevation of GOT and/or GFT, which were observed in 10 patients. 2) Dose-determination study Complicated UTI without indwelling catheters and also without prostatectomy, i.e., the 3rd, 4 th and 6 th groups were enrolled. The patients were randomly assigned to receive 5-day medication regimens with DQ-2556 at daily dosages of 0.5g b.i.d. (DQ-1.0 group) or l.Og b.i.d. group) and with ceftazidime (CAZ) at daily dosages of l.0g b.i.d. as the control group (CAZ group). The clinical efficacies of these three regimens were compared. Eleven patients in the DQ-1.0 group, 11 in the DQ-2.0 group and 12 in the CAZ group were evaluated. As for background characteristics of the patients, mild renal function failure was seen only in three patients in the DQ -2.0 group, and bacteria with low susceptibility to the compounds were distributed more in the DQ 1.0 and CAZ groups than in the DQ-2.0 group. Except for these characteristics, no significant differences were not found among the three groups. Overall clinical efficacy rates were 100% (11/11) in the DQ-1.0 group, 90.9% (10/11) in the DQ-2.0 group and 83.3% (10/12) in the CAZ group. Bacteriological eradication rates were 100% (12/12) in the DQ-1.0 group, 90.9% (10/11) in the DQ-2.0 group and 86.7% (13/15) in the CAZ group. As for these two rates, there were no significant differences among the three groups. On exclusion of Enterococcus faecalis which is not indicated, both the overall efficacy rate and the bacteriological eradication rate were both 100% in the CAZ group. A clinical adverse reactions were seen in only one patient in the DQ-2.0 group, who showed mild facial erythema. Abnormal laboratory findings were found in two patients in each of the three groups. As to the incidence of clinical and laboratory adverse reactions, there were no significant differences among the three groups. The results of this open clinical trial and the dose-determination study suggest that DQ-2556 is effective against complicated UTI and that the optimal daily dosage is 0.5g twice a day (0.5g b. i.d.), although a dose of more than l.0g b.i.d. may be needed for intractable UTI such as that associated with indwelling-catheter disease.

Original languageEnglish
Pages (from-to)1195-1217
Number of pages23
JournalChemotherapy
Volume41
Issue number11
DOIs
Publication statusPublished - Jan 1 1993

Fingerprint

Urinary Tract Infections
Anti-Bacterial Agents
Ceftazidime
Indwelling Catheters
DQ 2556
Clinical Trials
Bacteria
Enterococcus faecalis
Erythema
Prostatectomy
Gram-Negative Bacteria
Nausea
Multicenter Studies
Renal Insufficiency
Catheters

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases
  • Pharmacology
  • Drug Discovery
  • Oncology

Cite this

Clinical evaluation of DQ-2556, a new parenteral cephem antibiotic, and a dose-determination study in complicated urinary tract infections. / Kamidono, Sadao; Arakawa, Soichi; Yamashita, Masuo; Takagi, Shinsuke; Oshima, Hideo; Kataoka, Nobuo; Nakamura, Ichiro; Izumi, Takehiro; Yamada, Yuji; Sugimoto, Masayuki; Hazama, Minoru; Sengoku, Atsushi; Kumamoto, Yoshiaki; Hirose, Takaoki; Yamaguchi, Yasuhiro; Sato, Yoshikazu; Aso, Yoshio; Oshi, Masaya; Nito, Hiroshi; Kawamura, Nobuo; Inatsuchi, Hiroaki; Okada, Keishi; Hoshino, Hideaki; Tanaka, Motoaki; Suzuki, Keizo; Kawada, Yukimichi; Ban, Yoshihito; Takahashi, Yoshito; Tei, Kanhin; Takeda, Akihisa; Ohmori, Hiroyuki; Kumon, Hiromi; Hata, Kazuhiro; Yamada, Daisuke; Nanba, Katsuichi; Naoki, Nishitani Mitsuhata; Kumazawa, Joichi; Matsumoto, Tetsuro; Shi, Noritsugu; Yoshida, Takashi; Noguchi, Mitsuru; Nakayama, Tetsunori; Sagiyama, Kazuyuki; Komatsu, Kiyoshi; Hara, Sanshin; Itoh, Kenji; Omoto, Tetsuo; Koikawa, Yasuhiro; Goto, Ken; Kurozumi, Takeo; Omoto, Tetsuo; Ohi, Yoshitada; Kawahara, Motoshi; Yamauchi, Daishi; Shimada, Takeshi; Nagata, Shinichi; Kayajima, Tsuneyoshi; Imamura, Akira; Yagi, Shizuo; Ogawa, Nobuya; Deguchi, Koichi; Kataoka, Nobumasa.

In: Chemotherapy, Vol. 41, No. 11, 01.01.1993, p. 1195-1217.

Research output: Contribution to journalArticle

Kamidono, S, Arakawa, S, Yamashita, M, Takagi, S, Oshima, H, Kataoka, N, Nakamura, I, Izumi, T, Yamada, Y, Sugimoto, M, Hazama, M, Sengoku, A, Kumamoto, Y, Hirose, T, Yamaguchi, Y, Sato, Y, Aso, Y, Oshi, M, Nito, H, Kawamura, N, Inatsuchi, H, Okada, K, Hoshino, H, Tanaka, M, Suzuki, K, Kawada, Y, Ban, Y, Takahashi, Y, Tei, K, Takeda, A, Ohmori, H, Kumon, H, Hata, K, Yamada, D, Nanba, K, Naoki, NM, Kumazawa, J, Matsumoto, T, Shi, N, Yoshida, T, Noguchi, M, Nakayama, T, Sagiyama, K, Komatsu, K, Hara, S, Itoh, K, Omoto, T, Koikawa, Y, Goto, K, Kurozumi, T, Omoto, T, Ohi, Y, Kawahara, M, Yamauchi, D, Shimada, T, Nagata, S, Kayajima, T, Imamura, A, Yagi, S, Ogawa, N, Deguchi, K & Kataoka, N 1993, 'Clinical evaluation of DQ-2556, a new parenteral cephem antibiotic, and a dose-determination study in complicated urinary tract infections', Chemotherapy, vol. 41, no. 11, pp. 1195-1217. https://doi.org/10.11250/chemotherapy1953.41.1195
Kamidono, Sadao ; Arakawa, Soichi ; Yamashita, Masuo ; Takagi, Shinsuke ; Oshima, Hideo ; Kataoka, Nobuo ; Nakamura, Ichiro ; Izumi, Takehiro ; Yamada, Yuji ; Sugimoto, Masayuki ; Hazama, Minoru ; Sengoku, Atsushi ; Kumamoto, Yoshiaki ; Hirose, Takaoki ; Yamaguchi, Yasuhiro ; Sato, Yoshikazu ; Aso, Yoshio ; Oshi, Masaya ; Nito, Hiroshi ; Kawamura, Nobuo ; Inatsuchi, Hiroaki ; Okada, Keishi ; Hoshino, Hideaki ; Tanaka, Motoaki ; Suzuki, Keizo ; Kawada, Yukimichi ; Ban, Yoshihito ; Takahashi, Yoshito ; Tei, Kanhin ; Takeda, Akihisa ; Ohmori, Hiroyuki ; Kumon, Hiromi ; Hata, Kazuhiro ; Yamada, Daisuke ; Nanba, Katsuichi ; Naoki, Nishitani Mitsuhata ; Kumazawa, Joichi ; Matsumoto, Tetsuro ; Shi, Noritsugu ; Yoshida, Takashi ; Noguchi, Mitsuru ; Nakayama, Tetsunori ; Sagiyama, Kazuyuki ; Komatsu, Kiyoshi ; Hara, Sanshin ; Itoh, Kenji ; Omoto, Tetsuo ; Koikawa, Yasuhiro ; Goto, Ken ; Kurozumi, Takeo ; Omoto, Tetsuo ; Ohi, Yoshitada ; Kawahara, Motoshi ; Yamauchi, Daishi ; Shimada, Takeshi ; Nagata, Shinichi ; Kayajima, Tsuneyoshi ; Imamura, Akira ; Yagi, Shizuo ; Ogawa, Nobuya ; Deguchi, Koichi ; Kataoka, Nobumasa. / Clinical evaluation of DQ-2556, a new parenteral cephem antibiotic, and a dose-determination study in complicated urinary tract infections. In: Chemotherapy. 1993 ; Vol. 41, No. 11. pp. 1195-1217.
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abstract = "To evaluate the effectiveness and the safety of DQ-2556, a new parenteral cephem antibiotic, and to find its optimal dose in the treatment of complicated urinary tract infections (UTI) multicenter clinical trials were conducted. Data were summarized according to the criteria of the Japanease UTI committee (the third edition). 1) Open clinical trials DQ-2556 was administered mainly at doses of 0.5g, l.Og and 2.0g twice a day. In the 80 evaluable patients, 32 had excellent, 24 moderate and 24 poor results; the overall efficacy rate was 70.0{\%}. Twice-a-day medication was dose-dependently effective (moderate or excellent):efficacy rates for treatment at doses of 0.5 g b.i.d., 0.g b.i.d. and 2.0g b.i.d. were 59.1{\%} in 22 patients, 73.0{\%} in 37 patients and 80.0{\%} in 10 patients. DQ-2556 was effective in 77.8{\%} of 54 non-indwelling -catheter patients and in 53.8{\%} of 26 indwelling-catheter patients. The overall bacteriological eradication rate was 82.2{\%} (106/129);40 at 49 m-positive bacteria (81.6{\%}) and 66 of 80 gram-negative bacteria (82.5{\%}) were eradicated. Clinical adverse reactions were observed in three in 116 patients (2.6{\%}): a patient vomited severely with nausea three days after the commencement of treatment and another showed mild to moderate eruption. Laboratory adverse reactions were seen in 14 in 109 patients (12.8{\%}); the main findings were abnormalities of liver function represented by elevation of GOT and/or GFT, which were observed in 10 patients. 2) Dose-determination study Complicated UTI without indwelling catheters and also without prostatectomy, i.e., the 3rd, 4 th and 6 th groups were enrolled. The patients were randomly assigned to receive 5-day medication regimens with DQ-2556 at daily dosages of 0.5g b.i.d. (DQ-1.0 group) or l.Og b.i.d. group) and with ceftazidime (CAZ) at daily dosages of l.0g b.i.d. as the control group (CAZ group). The clinical efficacies of these three regimens were compared. Eleven patients in the DQ-1.0 group, 11 in the DQ-2.0 group and 12 in the CAZ group were evaluated. As for background characteristics of the patients, mild renal function failure was seen only in three patients in the DQ -2.0 group, and bacteria with low susceptibility to the compounds were distributed more in the DQ 1.0 and CAZ groups than in the DQ-2.0 group. Except for these characteristics, no significant differences were not found among the three groups. Overall clinical efficacy rates were 100{\%} (11/11) in the DQ-1.0 group, 90.9{\%} (10/11) in the DQ-2.0 group and 83.3{\%} (10/12) in the CAZ group. Bacteriological eradication rates were 100{\%} (12/12) in the DQ-1.0 group, 90.9{\%} (10/11) in the DQ-2.0 group and 86.7{\%} (13/15) in the CAZ group. As for these two rates, there were no significant differences among the three groups. On exclusion of Enterococcus faecalis which is not indicated, both the overall efficacy rate and the bacteriological eradication rate were both 100{\%} in the CAZ group. A clinical adverse reactions were seen in only one patient in the DQ-2.0 group, who showed mild facial erythema. Abnormal laboratory findings were found in two patients in each of the three groups. As to the incidence of clinical and laboratory adverse reactions, there were no significant differences among the three groups. The results of this open clinical trial and the dose-determination study suggest that DQ-2556 is effective against complicated UTI and that the optimal daily dosage is 0.5g twice a day (0.5g b. i.d.), although a dose of more than l.0g b.i.d. may be needed for intractable UTI such as that associated with indwelling-catheter disease.",
author = "Sadao Kamidono and Soichi Arakawa and Masuo Yamashita and Shinsuke Takagi and Hideo Oshima and Nobuo Kataoka and Ichiro Nakamura and Takehiro Izumi and Yuji Yamada and Masayuki Sugimoto and Minoru Hazama and Atsushi Sengoku and Yoshiaki Kumamoto and Takaoki Hirose and Yasuhiro Yamaguchi and Yoshikazu Sato and Yoshio Aso and Masaya Oshi and Hiroshi Nito and Nobuo Kawamura and Hiroaki Inatsuchi and Keishi Okada and Hideaki Hoshino and Motoaki Tanaka and Keizo Suzuki and Yukimichi Kawada and Yoshihito Ban and Yoshito Takahashi and Kanhin Tei and Akihisa Takeda and Hiroyuki Ohmori and Hiromi Kumon and Kazuhiro Hata and Daisuke Yamada and Katsuichi Nanba and Naoki, {Nishitani Mitsuhata} and Joichi Kumazawa and Tetsuro Matsumoto and Noritsugu Shi and Takashi Yoshida and Mitsuru Noguchi and Tetsunori Nakayama and Kazuyuki Sagiyama and Kiyoshi Komatsu and Sanshin Hara and Kenji Itoh and Tetsuo Omoto and Yasuhiro Koikawa and Ken Goto and Takeo Kurozumi and Tetsuo Omoto and Yoshitada Ohi and Motoshi Kawahara and Daishi Yamauchi and Takeshi Shimada and Shinichi Nagata and Tsuneyoshi Kayajima and Akira Imamura and Shizuo Yagi and Nobuya Ogawa and Koichi Deguchi and Nobumasa Kataoka",
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TY - JOUR

T1 - Clinical evaluation of DQ-2556, a new parenteral cephem antibiotic, and a dose-determination study in complicated urinary tract infections

AU - Kamidono, Sadao

AU - Arakawa, Soichi

AU - Yamashita, Masuo

AU - Takagi, Shinsuke

AU - Oshima, Hideo

AU - Kataoka, Nobuo

AU - Nakamura, Ichiro

AU - Izumi, Takehiro

AU - Yamada, Yuji

AU - Sugimoto, Masayuki

AU - Hazama, Minoru

AU - Sengoku, Atsushi

AU - Kumamoto, Yoshiaki

AU - Hirose, Takaoki

AU - Yamaguchi, Yasuhiro

AU - Sato, Yoshikazu

AU - Aso, Yoshio

AU - Oshi, Masaya

AU - Nito, Hiroshi

AU - Kawamura, Nobuo

AU - Inatsuchi, Hiroaki

AU - Okada, Keishi

AU - Hoshino, Hideaki

AU - Tanaka, Motoaki

AU - Suzuki, Keizo

AU - Kawada, Yukimichi

AU - Ban, Yoshihito

AU - Takahashi, Yoshito

AU - Tei, Kanhin

AU - Takeda, Akihisa

AU - Ohmori, Hiroyuki

AU - Kumon, Hiromi

AU - Hata, Kazuhiro

AU - Yamada, Daisuke

AU - Nanba, Katsuichi

AU - Naoki, Nishitani Mitsuhata

AU - Kumazawa, Joichi

AU - Matsumoto, Tetsuro

AU - Shi, Noritsugu

AU - Yoshida, Takashi

AU - Noguchi, Mitsuru

AU - Nakayama, Tetsunori

AU - Sagiyama, Kazuyuki

AU - Komatsu, Kiyoshi

AU - Hara, Sanshin

AU - Itoh, Kenji

AU - Omoto, Tetsuo

AU - Koikawa, Yasuhiro

AU - Goto, Ken

AU - Kurozumi, Takeo

AU - Omoto, Tetsuo

AU - Ohi, Yoshitada

AU - Kawahara, Motoshi

AU - Yamauchi, Daishi

AU - Shimada, Takeshi

AU - Nagata, Shinichi

AU - Kayajima, Tsuneyoshi

AU - Imamura, Akira

AU - Yagi, Shizuo

AU - Ogawa, Nobuya

AU - Deguchi, Koichi

AU - Kataoka, Nobumasa

PY - 1993/1/1

Y1 - 1993/1/1

N2 - To evaluate the effectiveness and the safety of DQ-2556, a new parenteral cephem antibiotic, and to find its optimal dose in the treatment of complicated urinary tract infections (UTI) multicenter clinical trials were conducted. Data were summarized according to the criteria of the Japanease UTI committee (the third edition). 1) Open clinical trials DQ-2556 was administered mainly at doses of 0.5g, l.Og and 2.0g twice a day. In the 80 evaluable patients, 32 had excellent, 24 moderate and 24 poor results; the overall efficacy rate was 70.0%. Twice-a-day medication was dose-dependently effective (moderate or excellent):efficacy rates for treatment at doses of 0.5 g b.i.d., 0.g b.i.d. and 2.0g b.i.d. were 59.1% in 22 patients, 73.0% in 37 patients and 80.0% in 10 patients. DQ-2556 was effective in 77.8% of 54 non-indwelling -catheter patients and in 53.8% of 26 indwelling-catheter patients. The overall bacteriological eradication rate was 82.2% (106/129);40 at 49 m-positive bacteria (81.6%) and 66 of 80 gram-negative bacteria (82.5%) were eradicated. Clinical adverse reactions were observed in three in 116 patients (2.6%): a patient vomited severely with nausea three days after the commencement of treatment and another showed mild to moderate eruption. Laboratory adverse reactions were seen in 14 in 109 patients (12.8%); the main findings were abnormalities of liver function represented by elevation of GOT and/or GFT, which were observed in 10 patients. 2) Dose-determination study Complicated UTI without indwelling catheters and also without prostatectomy, i.e., the 3rd, 4 th and 6 th groups were enrolled. The patients were randomly assigned to receive 5-day medication regimens with DQ-2556 at daily dosages of 0.5g b.i.d. (DQ-1.0 group) or l.Og b.i.d. group) and with ceftazidime (CAZ) at daily dosages of l.0g b.i.d. as the control group (CAZ group). The clinical efficacies of these three regimens were compared. Eleven patients in the DQ-1.0 group, 11 in the DQ-2.0 group and 12 in the CAZ group were evaluated. As for background characteristics of the patients, mild renal function failure was seen only in three patients in the DQ -2.0 group, and bacteria with low susceptibility to the compounds were distributed more in the DQ 1.0 and CAZ groups than in the DQ-2.0 group. Except for these characteristics, no significant differences were not found among the three groups. Overall clinical efficacy rates were 100% (11/11) in the DQ-1.0 group, 90.9% (10/11) in the DQ-2.0 group and 83.3% (10/12) in the CAZ group. Bacteriological eradication rates were 100% (12/12) in the DQ-1.0 group, 90.9% (10/11) in the DQ-2.0 group and 86.7% (13/15) in the CAZ group. As for these two rates, there were no significant differences among the three groups. On exclusion of Enterococcus faecalis which is not indicated, both the overall efficacy rate and the bacteriological eradication rate were both 100% in the CAZ group. A clinical adverse reactions were seen in only one patient in the DQ-2.0 group, who showed mild facial erythema. Abnormal laboratory findings were found in two patients in each of the three groups. As to the incidence of clinical and laboratory adverse reactions, there were no significant differences among the three groups. The results of this open clinical trial and the dose-determination study suggest that DQ-2556 is effective against complicated UTI and that the optimal daily dosage is 0.5g twice a day (0.5g b. i.d.), although a dose of more than l.0g b.i.d. may be needed for intractable UTI such as that associated with indwelling-catheter disease.

AB - To evaluate the effectiveness and the safety of DQ-2556, a new parenteral cephem antibiotic, and to find its optimal dose in the treatment of complicated urinary tract infections (UTI) multicenter clinical trials were conducted. Data were summarized according to the criteria of the Japanease UTI committee (the third edition). 1) Open clinical trials DQ-2556 was administered mainly at doses of 0.5g, l.Og and 2.0g twice a day. In the 80 evaluable patients, 32 had excellent, 24 moderate and 24 poor results; the overall efficacy rate was 70.0%. Twice-a-day medication was dose-dependently effective (moderate or excellent):efficacy rates for treatment at doses of 0.5 g b.i.d., 0.g b.i.d. and 2.0g b.i.d. were 59.1% in 22 patients, 73.0% in 37 patients and 80.0% in 10 patients. DQ-2556 was effective in 77.8% of 54 non-indwelling -catheter patients and in 53.8% of 26 indwelling-catheter patients. The overall bacteriological eradication rate was 82.2% (106/129);40 at 49 m-positive bacteria (81.6%) and 66 of 80 gram-negative bacteria (82.5%) were eradicated. Clinical adverse reactions were observed in three in 116 patients (2.6%): a patient vomited severely with nausea three days after the commencement of treatment and another showed mild to moderate eruption. Laboratory adverse reactions were seen in 14 in 109 patients (12.8%); the main findings were abnormalities of liver function represented by elevation of GOT and/or GFT, which were observed in 10 patients. 2) Dose-determination study Complicated UTI without indwelling catheters and also without prostatectomy, i.e., the 3rd, 4 th and 6 th groups were enrolled. The patients were randomly assigned to receive 5-day medication regimens with DQ-2556 at daily dosages of 0.5g b.i.d. (DQ-1.0 group) or l.Og b.i.d. group) and with ceftazidime (CAZ) at daily dosages of l.0g b.i.d. as the control group (CAZ group). The clinical efficacies of these three regimens were compared. Eleven patients in the DQ-1.0 group, 11 in the DQ-2.0 group and 12 in the CAZ group were evaluated. As for background characteristics of the patients, mild renal function failure was seen only in three patients in the DQ -2.0 group, and bacteria with low susceptibility to the compounds were distributed more in the DQ 1.0 and CAZ groups than in the DQ-2.0 group. Except for these characteristics, no significant differences were not found among the three groups. Overall clinical efficacy rates were 100% (11/11) in the DQ-1.0 group, 90.9% (10/11) in the DQ-2.0 group and 83.3% (10/12) in the CAZ group. Bacteriological eradication rates were 100% (12/12) in the DQ-1.0 group, 90.9% (10/11) in the DQ-2.0 group and 86.7% (13/15) in the CAZ group. As for these two rates, there were no significant differences among the three groups. On exclusion of Enterococcus faecalis which is not indicated, both the overall efficacy rate and the bacteriological eradication rate were both 100% in the CAZ group. A clinical adverse reactions were seen in only one patient in the DQ-2.0 group, who showed mild facial erythema. Abnormal laboratory findings were found in two patients in each of the three groups. As to the incidence of clinical and laboratory adverse reactions, there were no significant differences among the three groups. The results of this open clinical trial and the dose-determination study suggest that DQ-2556 is effective against complicated UTI and that the optimal daily dosage is 0.5g twice a day (0.5g b. i.d.), although a dose of more than l.0g b.i.d. may be needed for intractable UTI such as that associated with indwelling-catheter disease.

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U2 - 10.11250/chemotherapy1953.41.1195

DO - 10.11250/chemotherapy1953.41.1195

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