Abstract
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.
| Original language | English (US) |
|---|---|
| Article number | 297 |
| Journal | BMC Infectious Diseases |
| Volume | 12 |
| DOIs | |
| State | Published - Nov 12 2012 |
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Keywords
- CSSSI
- Glycylcycline
- Skin and skin structure infection
- Tigecycline
ASJC Scopus subject areas
- Infectious Diseases
Cite this
A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections. / Matthews, Peter; Alpert, Marc; Rahav, Galia; Rill, Denise; Zito, Edward; Gardiner, David; Pedersen, Ron; Babinchak, Timothy; McGovern, Paul C.; Armstrong, Peter; Bailey, Charles; Berbel, German; Bernstein, Jack; Bordon, Jose; Bruno-Murtha, Lou Ann; Caprioli, Russell; Casey, Kathleen; Chiang, Tom; Churukian, Allan; Flynn, William; Graham, Donald; Hao, Zijun; Kalassian, Kenneth; Kohler, Richard; Lee, Juliet; Leeds, William; Lucasti, Christopher; Malanoski, Gregory; Ko, Tien; Minnaganti, Venkat; Mogyoros, Miguel; Morgan, Bill; Moss, Charles; Muluk, Satish; Murthy, Rekha; O'Riordan, William; Pien, Francis; Polk, Hiram; Augustinsky, James B.; Salvaggio, Michelle; Smith, Leon; Smith, Raymond; Scott Stienecker, R.; Suh, Byungse; Vazquez, Jose Antonio; Weiland, Dennis E.; Wessolossky, Mireya; Zenilman, Jonathan; Abraham, Carl; Nathan, Richard; Sanchez, Phillip; Baird, Ian; Callahan, Charles; Schrock, Christian G.; Lau, William; Bochan, Markian R.; Somero, Michael; Klein, Stanley R.; Bellows, Charles; D'Hooghe, Annick; Ceulemans, Françoise; Gaillat, Jacques; Garo, Bernard; Eckmann, Christian; Haier, Joerg; Suter, Fredy; Bertani, Aldo; Acin, Francisco; Jiménez-Mejías, Manuel E.; Blanes, Ignacio; Regueiro, Dolores Sousa; Cakir, Nedim; Saba, Rabin; Giladi, Michael; Kanj-Sharara, Souha; Ahmed al Thaqafi, Abdulhakeem Okab; Ng, Wai Man; Burd, Andrew; Kurlekar, Utkrant; Rao, N. Raghupathi; Devarajan, T.; Choi, Junyong; Kim, Yeonsook; Pai, Hyunjoo; Park, Yoon Soo; Kumar, Suresh; Chow, Ting Soo; Crisostomo, Armando; Erasmo, Alex; Low, Jenny; Basson, M. M.; Breedt, Johannes; Matthews, P. A.; Ross, D. P.; Lin, His Hsun; Liao, Chun Hsing; Kung, Hsiang Chi; Chinswangwatanakul, Vitoon; Malathum, Kumthorn; Tantawichien, Terapong; Sergio Ricardo Filho Penteado, Ricardo Filho Penteado; Cardoso, Fernando; Gomez, Roosevelt Fajardo; Velazquez, David Fernandez; Tinoco-Favila, Juan Carlos; Poirier, Andre; Valiquette, Louis; Weiss, Karl; Grimard, Doria; Embil, John M.A.; Sanche, Steven E.; Smith, Ken; Chouinard, Sylvain; Dolcé, Patrick.
In: BMC Infectious Diseases, Vol. 12, 297, 12.11.2012.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections
AU - Matthews, Peter
AU - Alpert, Marc
AU - Rahav, Galia
AU - Rill, Denise
AU - Zito, Edward
AU - Gardiner, David
AU - Pedersen, Ron
AU - Babinchak, Timothy
AU - McGovern, Paul C.
AU - Armstrong, Peter
AU - Bailey, Charles
AU - Berbel, German
AU - Bernstein, Jack
AU - Bordon, Jose
AU - Bruno-Murtha, Lou Ann
AU - Caprioli, Russell
AU - Casey, Kathleen
AU - Chiang, Tom
AU - Churukian, Allan
AU - Flynn, William
AU - Graham, Donald
AU - Hao, Zijun
AU - Kalassian, Kenneth
AU - Kohler, Richard
AU - Lee, Juliet
AU - Leeds, William
AU - Lucasti, Christopher
AU - Malanoski, Gregory
AU - Ko, Tien
AU - Minnaganti, Venkat
AU - Mogyoros, Miguel
AU - Morgan, Bill
AU - Moss, Charles
AU - Muluk, Satish
AU - Murthy, Rekha
AU - O'Riordan, William
AU - Pien, Francis
AU - Polk, Hiram
AU - Augustinsky, James B.
AU - Salvaggio, Michelle
AU - Smith, Leon
AU - Smith, Raymond
AU - Scott Stienecker, R.
AU - Suh, Byungse
AU - Vazquez, Jose Antonio
AU - Weiland, Dennis E.
AU - Wessolossky, Mireya
AU - Zenilman, Jonathan
AU - Abraham, Carl
AU - Nathan, Richard
AU - Sanchez, Phillip
AU - Baird, Ian
AU - Callahan, Charles
AU - Schrock, Christian G.
AU - Lau, William
AU - Bochan, Markian R.
AU - Somero, Michael
AU - Klein, Stanley R.
AU - Bellows, Charles
AU - D'Hooghe, Annick
AU - Ceulemans, Françoise
AU - Gaillat, Jacques
AU - Garo, Bernard
AU - Eckmann, Christian
AU - Haier, Joerg
AU - Suter, Fredy
AU - Bertani, Aldo
AU - Acin, Francisco
AU - Jiménez-Mejías, Manuel E.
AU - Blanes, Ignacio
AU - Regueiro, Dolores Sousa
AU - Cakir, Nedim
AU - Saba, Rabin
AU - Giladi, Michael
AU - Kanj-Sharara, Souha
AU - Ahmed al Thaqafi, Abdulhakeem Okab
AU - Ng, Wai Man
AU - Burd, Andrew
AU - Kurlekar, Utkrant
AU - Rao, N. Raghupathi
AU - Devarajan, T.
AU - Choi, Junyong
AU - Kim, Yeonsook
AU - Pai, Hyunjoo
AU - Park, Yoon Soo
AU - Kumar, Suresh
AU - Chow, Ting Soo
AU - Crisostomo, Armando
AU - Erasmo, Alex
AU - Low, Jenny
AU - Basson, M. M.
AU - Breedt, Johannes
AU - Matthews, P. A.
AU - Ross, D. P.
AU - Lin, His Hsun
AU - Liao, Chun Hsing
AU - Kung, Hsiang Chi
AU - Chinswangwatanakul, Vitoon
AU - Malathum, Kumthorn
AU - Tantawichien, Terapong
AU - Sergio Ricardo Filho Penteado, Ricardo Filho Penteado
AU - Cardoso, Fernando
AU - Gomez, Roosevelt Fajardo
AU - Velazquez, David Fernandez
AU - Tinoco-Favila, Juan Carlos
AU - Poirier, Andre
AU - Valiquette, Louis
AU - Weiss, Karl
AU - Grimard, Doria
AU - Embil, John M.A.
AU - Sanche, Steven E.
AU - Smith, Ken
AU - Chouinard, Sylvain
AU - Dolcé, Patrick
PY - 2012/11/12
Y1 - 2012/11/12
N2 - 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.
AB - 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.
KW - CSSSI
KW - Glycylcycline
KW - Skin and skin structure infection
KW - Tigecycline
UR - http://www.scopus.com/inward/record.url?scp=84868633430&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84868633430&partnerID=8YFLogxK
U2 - 10.1186/1471-2334-12-297
DO - 10.1186/1471-2334-12-297
M3 - Article
VL - 12
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
SN - 1471-2334
M1 - 297
ER -