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Clinical efficacy of intravenous ciprofloxacin in patients with biliary tract infection: a randomized controlled trial with carbapenem as comparator

  • Original Article—Liver, Pancreas, and Biliary Tract
  • Published:
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Abstract

Background

We conducted a randomized controlled trial (RCT) to evaluate the clinical efficacy of an intravenous fluoroquinolone, ciprofloxacin (CIP), in patients with biliary tract infection requiring biliary drainage using imipenem/cilastatin (IPM/CS) as a control.

Methods

After the initial collection of bile, patients were randomly assigned to receive CIP at 300 mg twice daily by intravenous drip infusion or IPM/CS at 500 mg twice daily by intravenous drip infusion with the envelope method.

Results

The characteristics of the 104 patients evaluated for efficacy were well balanced. The clinical response rates were 100.0% (50/50 patients) in the CIP group and 94.4% (51/54) in the IPM/CS group. The difference in clinical response rate between groups (CIP, IPM/CS) was 5.56% (90% confidence interval: −0.26%, 13.95%), and the non-inferiority of CIP to IPM/CS was confirmed. Adverse events for which causal relationships with the study drugs could not be ruled out developed in 5.4% (3/56) of patients in the CIP group and 5.2% (3/58) of patients in the IPM/CS group, and none of them were serious.

Conclusions

The clinical efficacy of CIP in treating biliary tract infection requiring drainage was comparable to that of IPM/CS. These findings suggest that CIP is useful as a new therapeutic option for biliary tract infection.

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Notes

  1. Package insert of Tienam (imipenem/cilastatin).

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Acknowledgments

We express our deepest appreciation to the members of the BTI Therapy Research Group and to their institutions. For full details, please see the Appendix.

Author information

Authors and Affiliations

  1. Department of General Medicine, Hiroshima University Graduate School of Medical Science, Programs of Applied Medicine, Clinical Pharmacotherapy, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan

    Susumu Tazuma

  2. Division of Gastroenterology and Hepatology, Department of Internal Medicine of Toho University Omori Medical Center, 6-11-1, Oomori-nishi, Oota-ku, Tokyo, 143-8541, Japan

    Yoshinori Igarashi

  3. Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba, 260-8677, Japan

    Toshio Tsuyuguchi

  4. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-ku, Nagoya, 467-8601, Japan

    Hirotaka Ohara

  5. Department of Internal Medicine, Second Teaching Hospital, Fujita Health University School of Medicine, 3-6-10, Otobashi, Nakagawa-ku, Nagoya, 454-8509, Japan

    Kazuo Inui

  6. Department of Gastroenterology, Chugoku Rousai Hospital, 1-5-1, Hirotagaya, Kure, Hiroshima, 737-0193, Japan

    Toshihide Ohya

Authors
  1. Susumu Tazuma
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  2. Yoshinori Igarashi
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  3. Toshio Tsuyuguchi
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  4. Hirotaka Ohara
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  5. Kazuo Inui
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  6. Toshihide Ohya
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Consortia

On behalf of the BTI Therapy Research Group

Corresponding author

Correspondence to Susumu Tazuma.

Additional information

See the Appendix for full details of the BTI Therapy Research Group.

Appendix

Appendix

The Biliary Tract Infection (BTI) Therapy Research Group consists of the following physicians: Susumu Tazuma, Department of General Medicine, Hiroshima University Graduate School of Medical Science, Programs of Applied Medicine, Clinical Pharmacotherapy; Yoshinori Igarashi, Division of Gastroenterology and Hepatology, Department of Internal Medicine of Toho University Omori Medical Center; Hirotaka Ohara, Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences; Yoshinari Furukawa and Yukio Kuwata, Department of Gastroenterology, Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital; Hironori Tokumou, Yasumasa Asamoto, and Kei Shinagawa, Department of Gastroenterology, Hiroshima General Hospital; Keiji Hanada, Naomichi Hirano, Tomohiro Iiboshi, Yasutaka Ishii, and Fumiaki Hino, Department of Gastroenterology, Onomichi General Hospital; Hitoshi Yokoya and Souichirou Yamasaki, Department of Internal Medicine, Fuchu City Fuchu Kita Hospital; Minoru Sakomoto, Department of Gastroenterology, National Hospital Organaization Kure Medical Center; Yoshiaki Asami and Hiroyuki Ochikubo, Kajikawa Hospital; Toshihide Ohya, Yoshio Kuga, Daizaburou Hirata, Yoshito Takemura, and Aki Kogame, Department of Gastroenterology, Chugoku Rousai Hospital; Toshio Tsuyuguchi, Yuji Sakai, and Shin Tsuchiya, Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University; Yasuharu Kikuchi, Department of Gastroenterology, Numazu City Hospital; Takeshi Nihei, Department of Gastroenterology, Mito Saiseikai General Hospital; Hidekazu Kurata, Department of Gastroenterology, Shimotsuga General Hospital; Yoshimi Ishii, Department of Internal Medicine, Chiba Cardiovascular Center; Kazuo Inui, Kazumu Okushima, Hironao Miyoshi, Yuta Nakamura, and Masashi Hattori, Department of Internal Medicine, Second Teaching Hospital, Fujita Health University School of Medicine.

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Tazuma, S., Igarashi, Y., Tsuyuguchi, T. et al. Clinical efficacy of intravenous ciprofloxacin in patients with biliary tract infection: a randomized controlled trial with carbapenem as comparator. J Gastroenterol 44, 781–792 (2009). https://doi.org/10.1007/s00535-009-0067-1

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  • DOI: https://doi.org/10.1007/s00535-009-0067-1

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