Matthews, PeterPeterMatthewsAlpert, MarcMarcAlpertRahav, GaliaGaliaRahavRill, DeniseDeniseRillZito, EdwardEdwardZitoGardiner, DavidDavidGardinerPedersen, RonRonPedersenBabinchak, TimothyTimothyBabinchakMcGovern, Paul CPaul CMcGovernHSIANG-CHI KUNG etc.2018-09-102018-09-102012http://www.scopus.com/inward/record.url?eid=2-s2.0-84868633430&partnerID=MN8TOARShttp://scholars.lib.ntu.edu.tw/handle/123456789/371751Background: Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.Methods: In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).Results: In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.Conclusions: Tigecycline was generally safe and effective in the treatment of cSSSIs.Trial registration: ClinicalTrials.gov NCT00368537. ? 2012 Matthews et al.; licensee BioMed Central Ltd.CSSSI; Glycylcycline; Skin and skin structure infection; Tigecycline[SDGs]SDG3amoxicillin plus clavulanic acid; sultamicillin; tigecycline; vancomycin; abdominal pain; adult; anemia; antibiotic sensitivity; anxiety; article; cellulitis; comparative study; constipation; controlled study; debridement; diarrhea; dizziness; drug efficacy; drug safety; dyspepsia; Enterobacter cloacae; Enterococcus; eradication therapy; Escherichia coli; female; fever; headache; human; hypertension; hypokalemia; insomnia; intention to treat analysis; Klebsiella pneumoniae; major clinical study; male; methicillin resistant Staphylococcus aureus; microbiological examination; minimum inhibitory concentration; nausea; open study; pain; phase 3 clinical trial; phase 4 clinical trial; Proteus; pruritus; Pseudomonas aeruginosa; randomized controlled trial; side effect; skin infection; soft tissue infection; Staphylococcus aureus; Streptococcus agalactiae; Streptococcus anginosus; Streptococcus pyogenes; surgical drainage; thorax pain; treatment outcome; vomiting; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Female; Humans; Male; Middle Aged; Minocycline; Skin Diseases, Bacterial; Skin Diseases, Infectious; Sulbactamjournal article10.1186/1471-2334-12-297