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The US Food and Drug Administration (FDA) Adverse Events Reporting System (AERS) was searched for omadacycline (for reports including \u201c\n                      <jats:italic toggle=\"yes\">C. difficile<\/jats:italic>\n                      \u201d or \u201cCDI\u201d or \u201cgastrointestinal infection\u201d). The publications list publicly available at Paratek Pharmaceuticals, Inc. Web site was reviewed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction<\/jats:title>\n                    <jats:p>\n                      Publications presenting primary data on omadacycline and\n                      <jats:italic toggle=\"yes\">C. difficile<\/jats:italic>\n                      published in English were included.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis<\/jats:title>\n                    <jats:p>\n                      Preclinical and clinical evidence was extracted from 14 studies. No case reports in indexed literature and no reports on FDA AERS were found. Omadacycline has potent in vitro activity against many\n                      <jats:italic toggle=\"yes\">C. difficile<\/jats:italic>\n                      clinical strains and diverse ribotypes. In phase 3 studies, there were no reports of CDI in patients who received omadacycline for either community-acquired bacterial pneumonia or acute bacterial skin and skin structure infection.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice<\/jats:title>\n                    <jats:p>Omadacycline should be considered a low-risk antibiotic regarding its propensity to cause CDI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Reducing the burden of CDI on patients and the health care system should be a priority. Patients with appropriate indications who are at heightened risk of CDI may be suitable candidates for omadacycline therapy. In these patients, omadacycline may be preferable to antibiotics with a high CDI risk.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280221089007","type":"journal-article","created":{"date-parts":[[2022,6,3]],"date-time":"2022-06-03T05:08:52Z","timestamp":1654232932000},"page":"184-192","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":14,"title":["Omadacycline and\n                    <i>Clostridioides difficile<\/i>\n                    : A Systematic Review of Preclinical and Clinical Evidence"],"prefix":"10.1177","volume":"57","author":[{"given":"Kevin W.","family":"Garey","sequence":"first","affiliation":[{"name":"University of Houston College of Pharmacy, Houston, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Warren","family":"Rose","sequence":"additional","affiliation":[{"name":"School of Pharmacy, University of Wisconsin\u2013Madison, Madison, WI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1967-995X","authenticated-orcid":false,"given":"Kyle","family":"Gunter","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alisa W.","family":"Serio","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark H.","family":"Wilcox","sequence":"additional","affiliation":[{"name":"University of Leeds &amp; Leeds Teaching Hospitals, Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,6,3]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1910215."},{"key":"e_1_3_3_3_2","unstructured":"European Centre for Disease Prevention Control. 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