{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T13:26:20Z","timestamp":1785590780720,"version":"3.56.0"},"reference-count":74,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2013,3,1]],"date-time":"2013-03-01T00:00:00Z","timestamp":1362096000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2013,3]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>To review the pharmacology, chemistry, microbiology, in vitro susceptibility, mechanism of resistance, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, drug interactions, dosage, and administration of cethromycin, a new ketolide antibiotic.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DATA SOURCES<\/jats:title>\n                    <jats:p>Literature was obtained through searching PubMed (1950-October 2012), International Pharmaceutical Abstracts (1970-October 2012), and a bibliographic review of published articles. Search terms included cethromycin, ABT-773, ketolide antibiotic, and community-acquired pneumonia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>STUDY SELECTION AND DATA EXTRACTION<\/jats:title>\n                    <jats:p>All available in vitro and preclinical studies, as well as Phase 1, 2, and 3 clinical studies published in English were evaluated to summarize the pharmacology, chemistry, microbiology, efficacy, and safety of cethromycin in the treatment of respiratory tract infections.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DATA SYNTHESIS<\/jats:title>\n                    <jats:p>Cethromycin, a new ketolide, has a similar mechanism of action to telithromycin with an apparently better safety profile. Cethromycin displays in vitro activity against selected gram-positive, gram-negative, and atypical bacteria. The proposed indication of cethromycin is treatment of mild to moderate community-acquired bacterial pneumonia in patients aged 18 years or older. Based on clinical studies, the recommended dose is 300 mg orally once a day without regard to meals. Cethromycin has an orphan drug designation for tularemia, plague, and anthrax prophylaxis. The Food and Drug Administration denied approval for the treatment of community-acquired pneumonia in 2009; a recent noninferiority trial showed comparable efficacy between cethromycin and clarithromycin. Preliminary data on adverse effects suggest that cethromycin is safe and gastrointestinal adverse effects appear to be dose-related.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>Cethromycin appears to be a promising ketolide for the treatment of mild to moderate community-acquired pneumonia. It was denied approval by the FDA in 2009 pending more evidence to show its efficacy, with more recent studies showing its noninferiority to antibiotics for the same indication.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1345\/aph.1r435","type":"journal-article","created":{"date-parts":[[2013,3,5]],"date-time":"2013-03-05T21:38:58Z","timestamp":1362519538000},"page":"368-379","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":23,"title":["Cethromycin: A New Ketolide Antibiotic"],"prefix":"10.1177","volume":"47","author":[{"given":"Hanine","family":"Mansour","sequence":"first","affiliation":[{"name":"Hanine Mansour PharmD BCPS, at the time of writing, College of Pharmacy, University of Florida; now, Clinical Assistant Professor, Department of Pharmacy Practice, School of Pharmacy, Lebanese American University, Byblos, Lebanon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elias B","family":"Chahine","sequence":"additional","affiliation":[{"name":"Elias B Chahine PharmD BCPS (AQ-ID), Assistant Professor of Pharmacy Practice, Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lamis R","family":"Karaoui","sequence":"additional","affiliation":[{"name":"Lamis R Karaoui PharmD BCPS, Clinical Assistant Professor, Director of Experiential Education, Department of Pharmacy Practice, School of Pharmacy, Lebanese American University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rania M","family":"El-Lababidi","sequence":"additional","affiliation":[{"name":"Rania M El-Lababidi PharmD BCPS (AQ-ID) AAHIVP, at time of writing, Assistant Director, Clinical Services Department of Pharmacy, Florida Hospital, Orlando; now, Training Manager, Cleveland Clinic Abu Dhabi, Department of Pharmacy Services, Abu Dhabi, United Arab Emirates"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2016,12,21]]},"reference":[{"key":"bibr1-aph.1R435","volume-title":"The race against drug resistance","author":"Nugent R","year":"2010"},{"key":"bibr2-aph.1R435","first-page":"1","volume":"58","author":"Xu J","year":"2010","journal-title":"Natl Vital Stat Rep"},{"key":"bibr3-aph.1R435","unstructured":"3 Centers for Disease Control and Prevention. Fastats: pneumonia, September 2008. www.cdc.gov\/nchs\/fastats\/pneumonia.htm (accessed 2012 May 5)."},{"key":"bibr4-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1378\/chest.09-0285"},{"key":"bibr5-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01653-06"},{"key":"bibr6-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1016\/j.jinf.2007.04.006"},{"key":"bibr7-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00840-10"},{"key":"bibr8-aph.1R435","unstructured":"8 Cethromycin for the treatment of community-acquired bacterial pneumonia. FDA Briefing Document for Anti-Infective Drugs Advisory Committee Meeting June 2, 2009. http:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/Drugs\/Anti-InfectiveDrugsAdvisoryCommittee\/UCM161847.pdf (accessed 2012 Apr 30)."},{"key":"bibr9-aph.1R435","volume-title":"Dear healthcare professional letter","author":"Greene D","year":"2007"},{"key":"bibr10-aph.1R435","volume-title":"Package insert. 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Press release: September 29, 2009. http:\/\/www.advancedlifesciences.com (accessed 2012 Apr 29)."},{"key":"bibr16-aph.1R435","unstructured":"16 Advanced Life Sciences\u2019 Annual report. https:\/\/materials.proxyvote.com\/00765H (accessed 2012 May 9)."},{"key":"bibr17-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.05596-11"},{"key":"bibr18-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.17.3.387"},{"key":"bibr19-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1003833"},{"key":"bibr20-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1007\/s00284-001-0110-9"},{"key":"bibr21-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1016\/S1471-4892(02)00198-4"},{"key":"bibr22-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1016\/S0959-440X(03)00034-4"},{"key":"bibr23-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2958.2004.04290.x"},{"key":"bibr24-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.273.32.20073"},{"key":"bibr25-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-2836(03)00662-4"},{"key":"bibr26-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01425-08"},{"key":"bibr27-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1592\/phco.30.3.290"},{"key":"bibr28-aph.1R435","first-page":"1791","volume-title":"Infectious diseases. 2nd.","author":"Carbon CJ","year":"2004"},{"key":"bibr29-aph.1R435","unstructured":"29 Heine HS, Miller L, Bassett J, et al. Antimicrobial activity of cethromycin, a novel ketolide, tested against diverse collections of\n                      Bacillus anthracis\n                      (BA) and\n                      Yersinia pestis\n                      (YP). Presented at: 46th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 27\u201330, 2006."},{"key":"bibr30-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.46.3.783-786.2002"},{"key":"bibr31-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.10.2922-2924.2001"},{"key":"bibr32-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1016\/S0732-8893(01)00249-8"},{"key":"bibr33-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.44.2.447-449.2000"},{"key":"bibr34-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.44.7.1894-1899.2000"},{"key":"bibr35-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1086\/598975"},{"key":"bibr36-aph.1R435","unstructured":"36 Heine HS, Miller L, Bassett J, et al. Antimicrobial activity of cethromycin, a novel ketolide, tested against diverse collection of\n                      Francisella turensis\n                      (FT). Presented at: 47th Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17\u201320, 2007."},{"key":"bibr37-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.44.4.1112-1113.2000"},{"key":"bibr38-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkg154"},{"key":"bibr39-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkg371"},{"key":"bibr40-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2004.08.019"},{"key":"bibr41-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.47.1.39-42.2003"},{"key":"bibr42-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.1.345-348.2001"},{"key":"bibr43-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1007\/s100960000337"},{"key":"bibr44-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.8.2363-2367.2001"},{"key":"bibr45-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.44.9.2525-2529.2000"},{"key":"bibr46-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1086\/382687"},{"key":"bibr47-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.2.605-607.2004"},{"key":"bibr48-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1086\/318157"},{"key":"bibr49-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1086\/341978"},{"key":"bibr50-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.47.1.166-169.2003"},{"key":"bibr51-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkf237"},{"key":"bibr52-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.1.67-72.2001"},{"key":"bibr53-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2004.04.013"},{"key":"bibr54-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.9.3508-3515.2004"},{"key":"bibr55-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.47.3.1129-1131.2003"},{"key":"bibr56-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkg290"},{"key":"bibr57-aph.1R435","unstructured":"57 Guan Z, Fukumoto S, Fan L, et al. Human disposition and metabolism of orally administered [14C] ABT773 (abstract 942). Presented at: 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, December 16\u201319, 2001."},{"key":"bibr58-aph.1R435","unstructured":"58 Bukofzer S, Gustavson L, Eizhamer DA, et al. Safety and pharmacokinetics of cethromycin following administration of multiple doses to subjects with severe renal impairment (abstract A-797). Presented at: 47th Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17\u201320, 2007."},{"key":"bibr59-aph.1R435","unstructured":"59 Bukofzer S, Gustavson L, Eizhamer DA. Safety and pharmacokinetics of cethromycin following administration of single and multiple doses to subjects with mild and moderate chronic hepatic insufficiency (abstract A-796).afety and pharmacokinetics of cethromycin following administration of single and multiple doses to subjects with mild and moderate chronic hepatic insufficiency (abstract A-796). Presented at: 47th Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17\u201320, 2007."},{"key":"bibr60-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.46.10.3185-3192.2002"},{"key":"bibr61-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.12.3613-3615.2001"},{"key":"bibr62-aph.1R435","unstructured":"62 Food and Drug Administration. Searchable database for orphan designated and or approved products. http:\/\/www.accessdata.fda.gov\/scripts\/opdlisting\/oopd\/ (accessed 2012 Apr 29)."},{"key":"bibr63-aph.1R435","unstructured":"63 Advanced Life Sciences. Advanced Life Sciences\u2019 Restanza shows 100% survival in confirmatory anthrax study. Press release: June 23, 2009. http:\/\/www.advancedlifesciences.com (accessed 2012 Apr 29)."},{"key":"bibr64-aph.1R435","unstructured":"64 Advanced Life Sciences. Advanced Life Sciences\u2019 Restanza demonstrates efficacy in treating anthrax infection: study shows Restanza's significant efficacy after symptoms of anthrax infection are present. Press release: August 31, 2009. http:\/\/www.advancedlifesciences.com (accessed 2012 Apr 29)."},{"key":"bibr65-aph.1R435","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00632-11"},{"key":"bibr66-aph.1R435","unstructured":"66 Advanced Life Sciences. Advanced Life Sciences submits full proposal to NIAD for development of intravenous formulation of Restanza as a biodefense countermeasure. Press release: November 9, 2010. http:\/\/www.advancedlifesciences.com (accessed 2012 Apr 29)."},{"key":"bibr67-aph.1R435","unstructured":"67 Bukofzer S, Valdes J, Eiznhamer DA, et al. A phase 2 comparative study of the safety and efficacy of two oral doses of cethromycin for the treatment of community-acquired pneumonia (abstract: L-1442). In: Abstracts of the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 27\u201330, 2006."},{"key":"bibr68-aph.1R435","unstructured":"68 Bukofzer S, Gu Y, Eiznhamer DA, et al. A phase 2\/3 comparative study of the safety and efficacy of two oral doses of cethromycin for the treatment of community-acquired pneumonia (CAP) (abstract L-1445). In: Abstracts of the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 27\u201330, 2006."},{"key":"bibr69-aph.1R435","unstructured":"69 Milanesio NA, English ML, Fredericks CE, et al. A comparative study of the safety and efficacy of cethromycin (CER) to clarithromycin (CLR) for the treatment of community-acquired pneumonia (CAP) in adults (CL05\u2013001) (abstract L-683). In: Abstracts of the joint 48th Interscience Conference on Antimicrobial Agents and Chemotherapy\/45th Annual Meeting of the Infectious Diseases Society of America, Washington, DC, October 25\u201328, 2008."},{"key":"bibr70-aph.1R435","unstructured":"70 Advanced Life Sciences. Advanced Life Sciences presents clinical data on selected cethromycin trials at the Infectious Diseases Society of America 44th Annual Meeting. Press release: October 13, 2006. http:\/\/www.advancedlifesciences.com (accessed 2012 May 2)."},{"key":"bibr71-aph.1R435","unstructured":"71 Valdes J, Bukofzer S, Eiznhamer DA, et al. A phase 2 comparative study of the safety and efficacy of three oral doses of cethromycin for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) (abstract L-1443). In: Abstracts of the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 27\u201330, 2006."},{"key":"bibr72-aph.1R435","unstructured":"72 Bukofzer S, Gu Y, Eiznhamer DA, et al. A phase 3 comparative study of cethromycin 150 mg QD and levofloxacin 500 mg QD for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) (abstract L-1444). In: Abstracts of the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 27\u201330, 2006."},{"key":"bibr73-aph.1R435","unstructured":"73 Fredericks CE, Morganroth J, English ML, et al. A thorough QT study to define the ECG effects of cethromycin using a clinical and supratherapeutic dose compared to placebo and moxifloxacin in healthy subjects (CL07-001) (abstract). In: Abstracts of the Joint 48th Interscience Conference on Antimicrobial Agents and Chemotherapy\/46th Annual Meeting of the Infectious Diseases Society of America, Washington, DC, October 25\u201328, 2008."},{"key":"bibr74-aph.1R435","unstructured":"74 Gustavson LE, Ye X, Beason J, et al. ABT-773 has no clinically-important effect on the pharmacokinetics and safety of theophylline (abstract A-941). 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