A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections
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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, Peter; Alpert, Marc; Rahav, Galia; Rill, Denise; Zito, Edward; Gardiner, David; Pedersen, Ron; Babinchak, Timothy; McGovern, Paul C; Tigecycline 900 cSSSI Study Group.
in: BMC INFECT DIS, Jahrgang 12, 2012, S. 297.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 - Tigecycline 900 cSSSI Study Group
PY - 2012
Y1 - 2012
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 - Adult
KW - Aged
KW - Amoxicillin-Potassium Clavulanate Combination
KW - Ampicillin
KW - Anti-Bacterial Agents
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Minocycline
KW - Skin Diseases, Bacterial
KW - Skin Diseases, Infectious
KW - Sulbactam
U2 - 10.1186/1471-2334-12-297
DO - 10.1186/1471-2334-12-297
M3 - SCORING: Journal article
C2 - 23145952
VL - 12
SP - 297
JO - BMC INFECT DIS
JF - BMC INFECT DIS
SN - 1471-2334
ER -
