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Japanese Clinical Practice Guidelines for Management of Clostridioides (Clostridium) difficile infection

2022; Elsevier BV; Volume: 28; Issue: 8 Linguagem: Inglês

10.1016/j.jiac.2021.12.011

1437-7780

Hiroyuki Kunishima, Hiroki Ohge, Hiromichi Suzuki, Atsushi Nakamura, Kazuaki Matsumoto, Hiroshige Mikamo, N. Môri, Yoshitomo Morinaga, Katsunori Yanagihara, Yuka Yamagishi, Sadako Yoshizawa,

Microscopic Colitis

Toxigenic culture and cytotoxicity assays are standard tests for detecting C. difficile infection (CDI). Others include immunochromatographic strips, a rapid diagnostic test that detects glutamate dehydrogenase (GDH and toxins simultaneously, and the nucleic acid amplification test (NAAT) that detects C. difficile toxin-producing genes. NAAT may not be available in some facilities, so a 2-step method can be adopted where GDH-positive and toxin-negative specimens are selected first, and then toxigenic culture is performed for these specimens. The testing algorithms noted here do not stipulate approaches that individual facilities should opt for based on their characteristics and policies, because testing methods may be influenced by regional and institutional peculiarities. Whichever approach is taken, the diagnosis of CDI should be meticulous and thorough, with consideration given to the possibility that all tests may give false-positive and false-negative results in some instances. This algorithm comprises a rapid diagnostic kit for combined GDH and toxin A/B assay, followed by NAAT based on the results of the rapid diagnostic test. The sensitivity of the GDH assay is relatively high in general, so GDH-positive/toxin-positive results are considered confirmatory for CDI, while GDH-negative/toxin-negative results are considered non-CDI. Conversely, the sensitivity of the toxin assay using diarrheal stool specimens is low, so GDH-positive/toxin-negative results do not distinguish toxigenic strains from non-toxigenic strains. GDH-positive/toxin-negative specimens should therefore be subjected to NAAT. If toxigenicity is confirmed, CDI can be diagnosed by taking disease condition into account; if toxigenicity is not confirmed CDI is unlikely and anti-C. difficile medication is not required, in which case other causes of diarrhea need to be identified and/or ruled out.View Large Image Figure ViewerDownload Hi-res image Download (PPT) During outbreaks, proactive use of high sensitivity tests (i.e., NAAT and toxigenic culture) is recommended because of the possibility of false-negative results in patients with neutropenia who have undergone transplantation. Wider surveillance (including carriers) may be needed to determine the situation with regard to C. difficile outbreaks, and molecular epidemiological approaches (e.g., ribotyping) may become necessary. Toxigenic culture is time-intensive, but it offers detailed analysis of strains. Depending on the availability of NAAT in individual facilities, Algorithm 2a (NAAT without waiting for GDH and toxin assay results) or Algorithm 2b (NAAT based on GDH and toxin assay results) should be chosen. C. difficile is the most common anaerobic pathogen that causes nosocomial or healthcare-associated infections, and C. difficile infection manifests variously as diarrhea and pseudomembranous colitis. These clinical practice guidelines were prepared to improve the overall management of CDI. These guidelines include general information and clinical questions (CQs) about CDI based on the most recent evidence. However, it should be noted that epidemiological data on C. difficile in Japan are limited and that there is insufficient evidence overseas and in Japan for the classification of severity as well as on the dosage and administration of new therapies (e.g., probiotics, anti-toxin B human monoclonal antibody, fidaxomicin, and fecal microbiota transplantation) in addition to metronidazole and vancomycin. Thus, recommendations are made based on specialist opinions in order to reflect the clinical setting in Japan. We hope that these guidelines will help to advance C. difficile research in Japan and that the communication of the research results worldwide can lead to guideline revision. These clinical practice guidelines serve only as reference to guide the direction of CDI management. Given the paucity of evidence in Japan, clinical practice procedures should be chosen through collaboration between medical professionals and patients, taking into consideration the situation and characteristics of both the individual facilities and individual patients. The guidelines are not mandatory in clinical research or clinical practice, and allow for decision-making at the discretion of medical professionals. The COI committees of the Japanese Society of Chemotherapy and the Japanese Association for Infectious Diseases have oversight of potential COI in compliance with the COI guidelines. The COI of editorial board members responsible for producing the Japanese Clinical Practice Guidelines for Management of Clostridioides (Clostridium) difficile Infection are as follows.1)Research funding2)Fees for lectures and manuscript writing3)Personal income Hiroyuki Kunishima received lecture fees from MSD K.K. and Taisho Toyama Pharmaceutical Co., Ltd. Hiroki Ohge received lecture fees from Sumitomo Dainippon Pharma Co., Ltd., Pfizer Japan Inc., Taisho Toyama Pharmaceutical Co., Ltd., and MSD K.K. Hiroki Ohge received scholarship funds from Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., and Shionogi & Co., Ltd. Atsushi Nakamura received lecture fees from Taisho Toyama Pharmaceutical Co., Ltd., Pfizer Japan Inc., and MSD K.K. Hiroshige Mikamo received advisory fees from Toyama Chemical Co., Ltd. Hiroshige Mikamo received lecture fees from Astellas Pharma Inc., MSD K.K., Daiichi Sankyo Co., Ltd., Shionogi & Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Pfizer Japan Inc., Meiji Seika Pharma Co., Ltd., Toyama Chemical Co., Ltd., Asahi Kasei Pharma Corp., and Miyarisan Pharmaceutical Co., Ltd. Hiroshige Mikamo received manuscript fees from MSD K.K., Taisho Toyama Pharmaceutical Co., Ltd., and Pfizer Japan Inc. Hiroshige Mikamo received scholarship funds from Asahi Kasei Pharma Corp., Astellas Pharma Inc., MSD K.K., Eneforest Co., Ltd., Shionogi & Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Toyama Chemical Co., Ltd., Pfizer Japan Inc., FUJIFILM Pharma Co., Ltd., Hologic Japan Inc., Miyarisan Pharmaceutical Co., Ltd., and Meiji Seika Pharma Co., Ltd. Yoshitomo Morinaga received scholarship funds from SRL, Inc., Sumitomo Dainippon Pharma Co., Ltd., Pfizer Japan Inc., Daiichi Sankyo Co., Ltd., Toyama Chemical Co., Ltd., Astellas Pharma Inc., Mitsui Chemicals, Inc., and MSD K.K. Katsunori Yanagihara received lecture fees from MSD K.K., Pfizer Japan Inc., Meiji Seika Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Nippon Becton Dickinson Co., Ltd., bioMérieux Japan Ltd., and Astellas Pharma Inc. Katsunori Yanagihara received scholarship funds from SRL, Inc., Sumitomo Dainippon Pharma Co., Ltd., Pfizer Japan Inc., Daiichi Sankyo Co., Ltd., Toyama Chemical Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Astellas Pharma Inc., Mitsui Chemicals, Inc., MSD K.K., Shionogi & Co., Ltd., Nippon Becton Dickinson Co., Ltd., Hitachi High Technologies Co., Ltd., and Beckman Coulter K.K. Yuka Yamagishi received lecture fees from Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., and MSD K.K. Yuka Yamagishi received scholarship funds from MSD K.K., Asahi Kasei Pharma Corp., Astellas Pharma Inc., Eneforest Co., Ltd., Shionogi & Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Toyama Chemical Co., Ltd., Pfizer Japan Inc., FUJIFILM Pharma Co., Ltd., Miyarisan Pharmaceutical Co., Ltd., and Meiji Seika Pharma Co., Ltd. Hiromichi Suzuki, Kazuaki Matsumoto, Nobuaki Mori, and Sadako Yoshizawa have nothing to declare. Formulation of the present guidelines was entirely funded by the Japanese Society of Chemotherapy and the Japanese Association for Infectious Diseases.