{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T01:36:31Z","timestamp":1775525791994,"version":"3.50.1"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","license":[{"start":{"date-parts":[[2019,8,1]],"date-time":"2019-08-01T00:00:00Z","timestamp":1564617600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Early clinical response (ECR) is a new endpoint to determine whether a drug should be approved for community-acquired bacterial pneumonia in the United States. The Omadacycline for Pneumonia Treatment In the Community (OPTIC) phase III study demonstrated noninferiority of omadacycline to moxifloxacin using this endpoint. This study describes the performance of the ECR endpoint and clinical stability relative to a posttreatment evaluation (PTE) of clinical success.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>ECR was defined as symptom improvement 72\u2013120 hours after the first dose of study drug (ECR window), no use of rescue antibiotics, and patient survival. Clinical success at PTE was an investigator assessment of success. Clinical stability was defined based on vital sign stabilization, described in the American Thoracic Society and Infectious Diseases Society of America community-acquired pneumonia treatment guidelines.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>During the ECR window, ECR was achieved in 81.1% and 82.7% of omadacycline and moxifloxacin patients, respectively. Similar numbers of patients achieved clinical stability in each treatment group (omadacycline 74.6%, moxifloxacin 77.6%). The proportion of patients with improved symptoms who were considered clinically stable increased across the ECR window (69.2\u201377.6% for omadacycline; 68.0\u201379.7% for moxifloxacin). There was high concordance (&gt;70%) and high positive predictive value (&gt;90%) of ECR and clinical stability with overall clinical success at PTE.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Omadacycline was noninferior to moxifloxacin, based on a new ECR endpoint. Clinical stability was similarly high when measured in the same time frame as ECR. Both ECR and clinical stability showed high concordance and high positive predictive value with clinical success at PTE.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT02531438.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciz397","type":"journal-article","created":{"date-parts":[[2019,5,13]],"date-time":"2019-05-13T19:13:24Z","timestamp":1557774804000},"page":"S33-S39","source":"Crossref","is-referenced-by-count":17,"title":["Early Clinical Response in Community-acquired Bacterial Pneumonia: From Clinical Endpoint to Clinical Practice"],"prefix":"10.1093","volume":"69","author":[{"given":"Julio A","family":"Ramirez","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of Louisville, Kentucky"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evan","family":"Tzanis","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marla","family":"Curran","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Noble","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Surya","family":"Chitra","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Manley","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Courtney","family":"Kirsch","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul C","family":"McGovern","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2019,8,1]]},"reference":[{"key":"2019080101102804500_CIT0001","first-page":"1","article-title":"Deaths: leading causes for 2014","volume":"65","author":"Heron","year":"2016","journal-title":"Natl Vital Stat Rep"},{"key":"2019080101102804500_CIT0002","doi-asserted-by":"crossref","first-page":"1806","DOI":"10.1093\/cid\/cix647","article-title":"Adults hospitalized with pneumonia in the United States: incidence, epidemiology, and mortality","volume":"65","author":"Ramirez","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2019080101102804500_CIT0003","doi-asserted-by":"crossref","first-page":"427","DOI":"10.1016\/j.chest.2017.09.041","article-title":"Burden of pneumonia-associated hospitalizations: United States, 2001\u20132014","volume":"153","author":"Hayes","year":"2018","journal-title":"Chest"},{"key":"2019080101102804500_CIT0004","doi-asserted-by":"crossref","first-page":"E2120","DOI":"10.3390\/ijms17122120","article-title":"Microbial etiology of pneumonia: epidemiology, diagnosis and resistance patterns","volume":"17","author":"Cilloniz","year":"2016","journal-title":"Int J Mol Sci"},{"key":"2019080101102804500_CIT0005","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1056\/NEJMoa1800201","article-title":"Omadacycline for community-acquired bacterial pneumonia","volume":"380","author":"Stets","year":"2019","journal-title":"N Engl J Med"},{"key":"2019080101102804500_CIT0006","volume-title":"Guidance for industry community-acquired bacterial pneumonia: developing drugs for treatment","author":"Food and Drug Administration","year":"2014"},{"key":"2019080101102804500_CIT0007","doi-asserted-by":"crossref","first-page":"S27","DOI":"10.1086\/511159","article-title":"Infectious Diseases Society of America\/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults","volume":"44","author":"Mandell","year":"2007","journal-title":"Clin Infect Dis"},{"key":"2019080101102804500_CIT0008","doi-asserted-by":"crossref","first-page":"1730","DOI":"10.1164\/ajrccm.163.7.at1010","article-title":"Guidelines for the management of adults with community-acquired pneumonia. 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