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

Peter Matthews; Marc Alpert; Galia Rahav; Denise Rill; Edward Zito; David Gardiner; Ron Pedersen; Timothy Babinchak; Paul C. McGovern; Peter Armstrong; Charles Bailey; German Berbel; Jack Bernstein; Jose Bordon; Lou Ann Bruno-Murtha; Russell Caprioli; Kathleen Casey; Tom Chiang; Allan Churukian; William Flynn; Donald Graham; Zijun Hao; Kenneth Kalassian; Richard Kohler; Juliet Lee; William Leeds; Christopher Lucasti; Gregory Malanoski; Tien Ko; Venkat Minnaganti; Miguel Mogyoros; Bill Morgan; Charles Moss; Satish Muluk; Rekha Murthy; William O'Riordan; Francis Pien; Hiram Polk; James B. Augustinsky; Michelle Salvaggio; Leon Smith; Raymond Smith; R. Scott Stienecker; Byungse Suh; Jose Antonio Vazquez; Dennis E. Weiland; Mireya Wessolossky; Jonathan Zenilman; Carl Abraham; Richard Nathan; Phillip Sanchez; Ian Baird; Charles Callahan; Christian G. Schrock; William Lau; Markian R. Bochan; Michael Somero; Stanley R. Klein; Charles Bellows; Annick D'Hooghe; Françoise Ceulemans; Jacques Gaillat; Bernard Garo; Christian Eckmann; Joerg Haier; Fredy Suter; Aldo Bertani; Francisco Acin; Manuel E. Jiménez-Mejías; Ignacio Blanes; Dolores Sousa Regueiro; Nedim Cakir; Rabin Saba; Michael Giladi; Souha Kanj-Sharara; Abdulhakeem Okab Ahmed al Thaqafi; Wai Man Ng; Andrew Burd; Utkrant Kurlekar; N. Raghupathi Rao; T. Devarajan; Junyong Choi; Yeonsook Kim; Hyunjoo Pai; Yoon Soo Park; Suresh Kumar; Ting Soo Chow; Armando Crisostomo; Alex Erasmo; Jenny Low; M. M. Basson; Johannes Breedt; P. A. Matthews; D. P. Ross; His Hsun Lin; Chun Hsing Liao; Hsiang Chi Kung; Vitoon Chinswangwatanakul; Kumthorn Malathum; Terapong Tantawichien; Ricardo Filho Penteado Sergio Ricardo Filho Penteado; Fernando Cardoso; Roosevelt Fajardo Gomez; David Fernandez Velazquez; Juan Carlos Tinoco-Favila; Andre Poirier; Louis Valiquette; Karl Weiss; Doria Grimard; John M.A. Embil; Steven E. Sanche; Ken Smith; Sylvain Chouinard; Patrick Dolcé

doi:10.1186/1471-2334-12-297

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

Peter Matthews, Marc Alpert, Galia Rahav, Denise Rill, Edward Zito, David Gardiner, Ron Pedersen, Timothy Babinchak, Paul C. McGovern, Peter Armstrong, Charles Bailey, German Berbel, Jack Bernstein, Jose Bordon, Lou Ann Bruno-Murtha, Russell Caprioli, Kathleen Casey, Tom Chiang, Allan Churukian, William FlynnDonald Graham, Zijun Hao, Kenneth Kalassian, Richard Kohler, Juliet Lee, William Leeds, Christopher Lucasti, Gregory Malanoski, Tien Ko, Venkat Minnaganti, Miguel Mogyoros, Bill Morgan, Charles Moss, Satish Muluk, Rekha Murthy, William O'Riordan, Francis Pien, Hiram Polk, James B. Augustinsky, Michelle Salvaggio, Leon Smith, Raymond Smith, R. Scott Stienecker, Byungse Suh, Jose Antonio Vazquez, Dennis E. Weiland, Mireya Wessolossky, Jonathan Zenilman, Carl Abraham, Richard Nathan, Phillip Sanchez, Ian Baird, Charles Callahan, Christian G. Schrock, William Lau, Markian R. Bochan, Michael Somero, Stanley R. Klein, Charles Bellows, Annick D'Hooghe, Françoise Ceulemans, Jacques Gaillat, Bernard Garo, Christian Eckmann, Joerg Haier, Fredy Suter, Aldo Bertani, Francisco Acin, Manuel E. Jiménez-Mejías, Ignacio Blanes, Dolores Sousa Regueiro, Nedim Cakir, Rabin Saba, Michael Giladi, Souha Kanj-Sharara, Abdulhakeem Okab Ahmed al Thaqafi, Wai Man Ng, Andrew Burd, Utkrant Kurlekar, N. Raghupathi Rao, T. Devarajan, Junyong Choi, Yeonsook Kim, Hyunjoo Pai, Yoon Soo Park, Suresh Kumar, Ting Soo Chow, Armando Crisostomo, Alex Erasmo, Jenny Low, M. M. Basson, Johannes Breedt, P. A. Matthews, D. P. Ross, His Hsun Lin, Chun Hsing Liao, Hsiang Chi Kung, Vitoon Chinswangwatanakul, Kumthorn Malathum, Terapong Tantawichien, Ricardo Filho Penteado Sergio Ricardo Filho Penteado, Fernando Cardoso, Roosevelt Fajardo Gomez, David Fernandez Velazquez, Juan Carlos Tinoco-Favila, Andre Poirier, Louis Valiquette, Karl Weiss, Doria Grimard, John M.A. Embil, Steven E. Sanche, Ken Smith, Sylvain Chouinard, Patrick Dolcé

Infectious Disease

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

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	https://doi.org/10.1186/1471-2334-12-297
State	Published - Nov 12 2012

Keywords

CSSSI
Glycylcycline
Skin and skin structure infection
Tigecycline

ASJC Scopus subject areas

Infectious Diseases

Access to Document

10.1186/1471-2334-12-297

Cite this

Matthews, P., Alpert, M., Rahav, G., Rill, D., Zito, E., Gardiner, D., Pedersen, R., Babinchak, T., McGovern, P. C., Armstrong, P., Bailey, C., Berbel, G., Bernstein, J., Bordon, J., Bruno-Murtha, L. A., Caprioli, R., Casey, K., Chiang, T., Churukian, A., ... Dolcé, P. (2012). A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections. BMC Infectious Diseases, 12, [297]. https://doi.org/10.1186/1471-2334-12-297

Matthews, P, Alpert, M, Rahav, G, Rill, D, Zito, E, Gardiner, D, Pedersen, R, Babinchak, T, McGovern, PC, Armstrong, P, Bailey, C, Berbel, G, Bernstein, J, Bordon, J, Bruno-Murtha, LA, Caprioli, R, Casey, K, Chiang, T, Churukian, A, Flynn, W, Graham, D, Hao, Z, Kalassian, K, Kohler, R, Lee, J, Leeds, W, Lucasti, C, Malanoski, G, Ko, T, Minnaganti, V, Mogyoros, M, Morgan, B, Moss, C, Muluk, S, Murthy, R, O'Riordan, W, Pien, F, Polk, H, Augustinsky, JB, Salvaggio, M, Smith, L, Smith, R, Scott Stienecker, R, Suh, B, Vazquez, JA, Weiland, DE, Wessolossky, M, Zenilman, J, Abraham, C, Nathan, R, Sanchez, P, Baird, I, Callahan, C, Schrock, CG, Lau, W, Bochan, MR, Somero, M, Klein, SR, Bellows, C, D'Hooghe, A, Ceulemans, F, Gaillat, J, Garo, B, Eckmann, C, Haier, J, Suter, F, Bertani, A, Acin, F, Jiménez-Mejías, ME, Blanes, I, Regueiro, DS, Cakir, N, Saba, R, Giladi, M, Kanj-Sharara, S, Ahmed al Thaqafi, AO, Ng, WM, Burd, A, Kurlekar, U, Rao, NR, Devarajan, T, Choi, J, Kim, Y, Pai, H, Park, YS, Kumar, S, Chow, TS, Crisostomo, A, Erasmo, A, Low, J, Basson, MM, Breedt, J, Matthews, PA, Ross, DP, Lin, HH, Liao, CH, Kung, HC, Chinswangwatanakul, V, Malathum, K, Tantawichien, T, Sergio Ricardo Filho Penteado, RFP, Cardoso, F, Gomez, RF, Velazquez, DF, Tinoco-Favila, JC, Poirier, A, Valiquette, L, Weiss, K, Grimard, D, Embil, JMA, Sanche, SE, Smith, K, Chouinard, S & Dolcé, P 2012, 'A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections', BMC Infectious Diseases, vol. 12, 297. https://doi.org/10.1186/1471-2334-12-297

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

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.",

keywords = "CSSSI, Glycylcycline, Skin and skin structure infection, Tigecycline",

author = "Peter Matthews and Marc Alpert and Galia Rahav and Denise Rill and Edward Zito and David Gardiner and Ron Pedersen and Timothy Babinchak and McGovern, {Paul C.} and Peter Armstrong and Charles Bailey and German Berbel and Jack Bernstein and Jose Bordon and Bruno-Murtha, {Lou Ann} and Russell Caprioli and Kathleen Casey and Tom Chiang and Allan Churukian and William Flynn and Donald Graham and Zijun Hao and Kenneth Kalassian and Richard Kohler and Juliet Lee and William Leeds and Christopher Lucasti and Gregory Malanoski and Tien Ko and Venkat Minnaganti and Miguel Mogyoros and Bill Morgan and Charles Moss and Satish Muluk and Rekha Murthy and William O'Riordan and Francis Pien and Hiram Polk and Augustinsky, {James B.} and Michelle Salvaggio and Leon Smith and Raymond Smith and {Scott Stienecker}, R. and Byungse Suh and Vazquez, {Jose Antonio} and Weiland, {Dennis E.} and Mireya Wessolossky and Jonathan Zenilman and Carl Abraham and Richard Nathan and Phillip Sanchez and Ian Baird and Charles Callahan and Schrock, {Christian G.} and William Lau and Bochan, {Markian R.} and Michael Somero and Klein, {Stanley R.} and Charles Bellows and Annick D'Hooghe and Fran{\c c}oise Ceulemans and Jacques Gaillat and Bernard Garo and Christian Eckmann and Joerg Haier and Fredy Suter and Aldo Bertani and Francisco Acin and Jim{\'e}nez-Mej{\'i}as, {Manuel E.} and Ignacio Blanes and Regueiro, {Dolores Sousa} and Nedim Cakir and Rabin Saba and Michael Giladi and Souha Kanj-Sharara and {Ahmed al Thaqafi}, {Abdulhakeem Okab} and Ng, {Wai Man} and Andrew Burd and Utkrant Kurlekar and Rao, {N. Raghupathi} and T. Devarajan and Junyong Choi and Yeonsook Kim and Hyunjoo Pai and Park, {Yoon Soo} and Suresh Kumar and Chow, {Ting Soo} and Armando Crisostomo and Alex Erasmo and Jenny Low and Basson, {M. M.} and Johannes Breedt and Matthews, {P. A.} and Ross, {D. P.} and Lin, {His Hsun} and Liao, {Chun Hsing} and Kung, {Hsiang Chi} and Vitoon Chinswangwatanakul and Kumthorn Malathum and Terapong Tantawichien and {Sergio Ricardo Filho Penteado}, {Ricardo Filho Penteado} and Fernando Cardoso and Gomez, {Roosevelt Fajardo} and Velazquez, {David Fernandez} and Tinoco-Favila, {Juan Carlos} and Andre Poirier and Louis Valiquette and Karl Weiss and Doria Grimard and Embil, {John M.A.} and Sanche, {Steven E.} and Ken Smith and Sylvain Chouinard and Patrick Dolc{\'e}",

note = "Funding Information: This study was sponsored by Wyeth Research, which was acquired by Pfizer Inc in October 2009. These results were presented in part at the 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, 2010. D. Rill, P. McGovern, and E. Zito are employees of Pfizer Inc, USA. T. Babinchak and D. Gardiner are former employees of Pfizer Inc and Wyeth Research.",

year = "2012",

month = nov,

day = "12",

doi = "10.1186/1471-2334-12-297",

language = "English (US)",

volume = "12",

journal = "BMC Infectious Diseases",

issn = "1471-2334",

publisher = "BioMed Central",

}

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

N1 - Funding Information: This study was sponsored by Wyeth Research, which was acquired by Pfizer Inc in October 2009. These results were presented in part at the 20th European Congress of Clinical Microbiology and Infectious Diseases, Vienna, Austria, 2010. D. Rill, P. McGovern, and E. Zito are employees of Pfizer Inc, USA. T. Babinchak and D. Gardiner are former employees of Pfizer Inc and Wyeth Research.

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

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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

C2 - 23145952

AN - SCOPUS:84868633430

VL - 12

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

SN - 1471-2334

M1 - 297

ER -

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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