A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections

Matthews; Alpert, M.; Rahav, G.; Rill, D.; Zito, E.; Gardiner, D.; Pedersen, R.; Babinchak, T.; McGovern, P.C.; Armstrong, P.; Berbel, G.; Bernstein, J.; Bordon, J.; Bruno-Murtha, L.A.; Caprioli, R.; Casey, K.; Chiang, T.; Churukian, A.; Flynn, W.; Graham, D.; Hao, Z.; Kalassian, K.; Kohler, R.; Lee, J.; Lucasti, C.; Malanoski, G.; Ko, T.; Minnaganti, V.; Mogyoros, M.; Morgan, B.; Moss, C.; Muluk, S.; O'Riordan, W.; Polk, H.; Salvaggio, M.; Smith, L.; Smith, R.; Scott Stienecker, R.; Suh, B.; Vazquez, J.; Wessolossky, M.; Zenilman, J.; Sanchez, P.; Baird, I.; Callahan, C.; Schrock, C.G.; Bochan, M.R.; Somero, M.; Klein, S.R.; Bellows, C.; D'Hooghe, A.; Ceulemans, F.; Gaillat, J.; Garo, B.; Eckmann, C.; Haier, J.; Suter, F.; Bertani, A.; Acin, F.; Jiménez-Mejías, M.E.; Blanes, I.; Regueiro, D.S.; Cakir, N.; Saba, R.; Giladi, M.; Kanj-Sharara, S.; Ahmed al Thaqafi, A.O.; Ng, W.-M.; Burd, A.; Kurlekar, U.; Rao, N.R.; Devarajan, T.; Choi, J.; Kim, Y.; Pai, H.; Park, Y.-S.; Kumar, S.; Chow, T.S.; Crisostomo, A.; Erasmo, A.; Low, J.; Basson; Breedt, J.; Matthews; Ross, D.P.; Lin, H.-H.; Liao, C.-H.; Kung, H.-C.; Chinswangwatanakul, V.; Malathum, K.; Tantawichien, T.; Sergio Ricardo Filho Penteado; Cardoso, F.; Gomez, R.F.; Velazquez, D.F.; Poirier, A.; Valiquette, L.; Weiss, K.; Grimard, D.; Embil, J.M.A.; Sanche, S.E.; Smith, K.; Chouinard, S.; Dolcé, P.

doi:10.1186/1471-2334-12-297

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A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections

Matthews;
Alpert, M.;
Rahav, G.;
Rill, D.;
Zito, E.;
외 99명

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32

초록

Background: 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.

키워드

CSSSI; Glycylcycline; Skin and skin structure infection; Tigecycline; amoxicillin 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; Sulbactam

제목: A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections

저자: Matthews; Alpert, M.; Rahav, G.; Rill, D.; Zito, E.; Gardiner, D.; Pedersen, R.; Babinchak, T.; McGovern, P.C.; Armstrong, P.; Berbel, G.; Bernstein, J.; Bordon, J.; Bruno-Murtha, L.A.; Caprioli, R.; Casey, K.; Chiang, T.; Churukian, A.; Flynn, W.; Graham, D.; Hao, Z.; Kalassian, K.; Kohler, R.; Lee, J.; Lucasti, C.; Malanoski, G.; Ko, T.; Minnaganti, V.; Mogyoros, M.; Morgan, B.; Moss, C.; Muluk, S.; O'Riordan, W.; Polk, H.; Salvaggio, M.; Smith, L.; Smith, R.; Scott Stienecker, R.; Suh, B.; Vazquez, J.; Wessolossky, M.; Zenilman, J.; Sanchez, P.; Baird, I.; Callahan, C.; Schrock, C.G.; Bochan, M.R.; Somero, M.; Klein, S.R.; Bellows, C.; D'Hooghe, A.; Ceulemans, F.; Gaillat, J.; Garo, B.; Eckmann, C.; Haier, J.; Suter, F.; Bertani, A.; Acin, F.; Jiménez-Mejías, M.E.; Blanes, I.; Regueiro, D.S.; Cakir, N.; Saba, R.; Giladi, M.; Kanj-Sharara, S.; Ahmed al Thaqafi, A.O.; Ng, W.-M.; Burd, A.; Kurlekar, U.; Rao, N.R.; Devarajan, T.; Choi, J.; Kim, Y.; Pai, H.; Park, Y.-S.; Kumar, S.; Chow, T.S.; Crisostomo, A.; Erasmo, A.; Low, J.; Basson; Breedt, J.; Matthews; Ross, D.P.; Lin, H.-H.; Liao, C.-H.; Kung, H.-C.; Chinswangwatanakul, V.; Malathum, K.; Tantawichien, T.; Sergio Ricardo Filho Penteado; Cardoso, F.; Gomez, R.F.; Velazquez, D.F.; Poirier, A.; Valiquette, L.; Weiss, K.; Grimard, D.; Embil, J.M.A.; Sanche, S.E.; Smith, K.; Chouinard, S.; Dolcé, P.

DOI: 10.1186/1471-2334-12-297

발행일: 2012-11

유형: Article

저널명: BMC Infectious Diseases

권: 12