{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:37:09Z","timestamp":1787017029401,"version":"build-2736575974"},"reference-count":32,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2023,5,8]],"date-time":"2023-05-08T00:00:00Z","timestamp":1683504000000},"content-version":"unspecified","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Hvidovre Hospital Strategic Research Fund","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Capital Region of Denmark Research Fund","award":["A6688"],"award-info":[{"award-number":["A6688"]}]},{"name":"Danish Regions Medicine Grant","award":["EMN-2019-01055"],"award-info":[{"award-number":["EMN-2019-01055"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,4,19]]},"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Prolonged use of antibiotics is closely related to antibiotic-associated infections, antimicrobial resistance and adverse drug events. The optimal duration of antibiotic treatment for Gram-negative bacteremia (GNB) with a urinary tract source of infection is poorly defined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      Investigator-initiated multicentre, non-blinded, non-inferiority randomised controlled trial with two parallel treatment arms. One arm will receive shortened antibiotic treatment of 5\u2009days and the other arm will receive antibiotic treatment of 7\u2009days or longer. Randomisation will occur in equal proportion (1:1) no later than day 5 of effective antibiotic treatment as determined by antibiogram. Immunosuppressed patients and those with GNB due to non-fermenting bacilli (\n                      <jats:italic>Acinetobacter<\/jats:italic>\n                      spp,\n                      <jats:italic>Pseudomonas<\/jats:italic>\n                      spp),\n                      <jats:italic>Brucella<\/jats:italic>\n                      spp,\n                      <jats:italic>Fusobacterium<\/jats:italic>\n                      spp or polymicrobial growth are ineligible.\n                    <\/jats:p>\n                    <jats:p>\n                      The primary endpoint is 90-day survival without clinical or microbiological failure to treatment. Secondary endpoints include all-cause mortality, total duration of antibiotic treatment, hospital readmission and\n                      <jats:italic>Clostridioides difficile<\/jats:italic>\n                      infection. Interim safety analysis will be performed after the recruitment of every 100 patients. Given an event rate of 12%, a non-inferiority margin of 10%, and 90% power, the required sample size to determine non-inferiority is 380 patients. Analyses will be performed on both intention-to-treat and per-protocol populations.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study is approved by the Danish Regional Committee on Health Research (H-19085920) and the Danish Medicines Agency (2019-003282-17). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ClinicalTrials.Gov:NCT04291768\">ClinicalTrials.Gov:NCT04291768<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-068606","type":"journal-article","created":{"date-parts":[[2023,5,8]],"date-time":"2023-05-08T12:04:37Z","timestamp":1683547477000},"page":"e068606","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Short course antibiotic treatment of Gram-negative bacteraemia (GNB5): a study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04291768","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0133-7345","authenticated-orcid":false,"given":"Sandra","family":"Tingsg\u00e5rd","sequence":"first","affiliation":[{"name":"Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0653-1289","authenticated-orcid":false,"given":"Simone Bastrup","family":"Israelsen","sequence":"additional","affiliation":[{"name":"Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Thorlacius-Ussing","sequence":"additional","affiliation":[{"name":"Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karina","family":"Frahm Kirk","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birgitte","family":"Lindegaard","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hiller\u00f8d, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isik S","family":"Johansen","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Odense Universitetshospital, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Knudsen","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Lunding","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Section for Infectious Diseases, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pernille","family":"Ravn","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Section for Infectious Diseases, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"\u00d8stergaard Andersen","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Benfield","sequence":"additional","affiliation":[{"name":"Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,5,8]]},"reference":[{"key":"2025121604243995000_13.5.e068606.1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.49.2.760-766.2005"},{"key":"2025121604243995000_13.5.e068606.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2004.05.003"},{"key":"2025121604243995000_13.5.e068606.3","doi-asserted-by":"publisher","DOI":"10.1111\/1469-0691.12028"},{"key":"2025121604243995000_13.5.e068606.4","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciq069"},{"key":"2025121604243995000_13.5.e068606.5","unstructured":"DANMAP 2017 . 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