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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections
BMC Infectious Diseases, Volume 12, Article 297, Year 2012
Notification
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Description
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.
Authors & Co-Authors
Matthews, Peter
Unknown Affiliation
Alpert, Marc
United States, Lansdale
Central Montgomery Surgical Associates
Rahav, Galia
Israel, Tel Hashomer Tel Aviv
Chaim Sheba Medical Center Israel
Rill, Denise
United States, New York
Pfizer Inc.
Zito, Edward T.
United States, New York
Pfizer Inc.
Gardiner, David
United States, New York
Pfizer Inc.
Pedersen, Ronald D.
United States, New York
Pfizer Inc.
Babinchak, Timothy J.
United States, New York
Pfizer Inc.
McGovern, Paul C.
United States, New York
Pfizer Inc.
Armstrong, Peter
United States, Fort Gordon
Eisenhower Army Medical Center
Bailey, Charles
Unknown Affiliation
Berbel, German
United States, Fort Worth
Healthfirst Medical Group Research
Bernstein, Jack
United States
Va Medical Center
Bordon, Jose
United States, Ne Washington
Providence Hospital Clinical Research Center
Bruno-Murtha, Lou Ann
United States, Cambridge
Cambridge Health Alliance
Caprioli, Russell
United States, New Hyde Park
Long Island Jewish Medical Center
Casey, Kathleen King
United States, Neptune City
Jersey Shore University Medical Center
Chiang, Tom
United States
Va Medical Center
Churukian, Allan
United States, San Diego
Estudysite
Flynn, William
United States, Buffalo
Erie County Medical Center
Graham, Donald R.
United States, Springfield
Springfield Clinic
Hao, Zijun
United States, Lincoln
Saint Elizabeth Regional Medical Center
Kalassian, Kenneth
United States, Atlanta
Emory University Hospital
Kohler, Richard
United States, Indianapolis
Wishard Memorial Hospital
Lee, Juliet
United States, Washington
Medical Faculty Associates
Leeds, William
Unknown Affiliation
Lucasti, Christopher J.
United States, Somers Point
South Jersey Infectious Disease
Malanoski, Gregory
United States
Ams Infectious Disease
Ko, Tien
United States, Houston
Lbj General Hospital
Minnaganti, Venkat
United States, Decatur
Cancer Care Specialists of Central Illinois
Mogyoros, Miguel
United States, Oakland
Kaiser Permanente
Morgan, Bill
United States, Fort Worth
Harris Methodist Fort Worth Hospital
Moss, Charles
United States, Hackensack
Moss and Geuder Surgical Group
Muluk, Satish
United States, Pittsburgh
Allegheny General Hospital
Murthy, Rekha K.
Unknown Affiliation
O'Riordan, William D.
United States, San Diego
Estudysite
Pien, Frances
Unknown Affiliation
Polk, Hiram
United States, Louisville
University of Louisville
Augustinsky, James B.
Unknown Affiliation
Salvaggio, Michelle
United States, Oklahoma City
Infectious Diseases Institute Clinical Trials Unit
Smith, Leon
United States, Newark
Saint Michael's Medical Center
Smith, Raymond
United States, Albany
Albany va Medical Center
Scott Stienecker, R.
United States, Lima
Regional Infectious Diseases-infusion Center
Suh, B.
United States, Philadelphia
Section of Infectious Diseases
Vázquez, José A.
United States, Detroit
Henry Ford Health System
Weiland, Dennis E.
Unknown Affiliation
Wessolossky, Mireya
United States, Worcester
University of Massachusetts Chan Medical School
Zenilman, Jonathan Mark
United States, Baltimore
Johns Hopkins Bayview Medical Center
Abraham, Carl
Unknown Affiliation
Nathan, Richard A.
Unknown Affiliation
Sanchez, Phillip
United States, Orlando
Southeastern Clinical Research Consultants
Baird, Ian
United States, Columbus
Remington Davis Clinical Research
Callahan, Charles
United States, Vero Beach
Indian River Medical Center
Schrock, Christian
United States, Minneapolis
Infectious Diseases Minneapolis Ltd.
Lau, William
Unknown Affiliation
Bochan, Markian R.
United States, Indianapolis
Infectious Diseases of Indiana
Somero, Michael
United States
Research Office
Klein, Stanley
United States, Torrance
Harbor-ucla Medical Center
Bellows, Charles
United States, New Orleans
Tulane University Health Sciences Center
D'Hooghe, Annick
Belgium, Antwerpen
St-elisabeth Ziekenhuis
Ceulemans, Françoise
Belgium
Center Hospitalier Regional de Namur
Gaíllat, Jacques
France, Annecy
Center Hospitalier General D'annecy
Garo, Bernard J.
France, Brest
Hopital de la Cavale Blanche
Eckmann, Christian
Germany, Lubeck
Universitaetsklinikum
Haier, J.
Germany, Munster
University of Münster
Suter, Fredy
Italy, Bergamo
Divisione Di Malattie Infettive
Bertani, Aldo
Italy
A.o.u. Ospedali Riuniti Umberto I G.m Lancisi-g. Salesi
Acin, Francisco
Spain, Getafe
Hospital Universitario de Getafe
Jiménez-Mejías, Manuel E.
Spain, Sevilla
Hospital Universitario Virgen Del Rocío
Blanes, Ignacio
Spain, Valencia
Hospital Universitario Dr. Peset
Regueiro, Dolores Sousa
Spain, La Coruna
Comolejo Hospitalaro
Cakir, Nedim
Turkey, Izmir
Dokuz Eylül Üniversitesi
Saba, Rabin
Turkey, Antalya
Akdeniz Üniversitesi
Giladi, Michael
Israel, Tel Aviv-yafo
Infectious Diseases Unit
Kanj, Souha S.
Lebanon, Beirut
American University of Beirut
Ahmed al Thaqafi, Abdulhakeem Okab
Saudi Arabia, Jeddah
King Abdulaziz Medical City - Jeddah
Ng, Wai Man
Hong Kong
Queen Mary Hospital Hong Kong
Burd, Andrew
Hong Kong
Prince of Wales Hospital Hong Kong
Kurlekar, Utkrant
India
Deenanath Mangeshkar Hospital
Rao, N. Raghupathi
India, Hyderabad
Apollo Hospitals
Devarajan, T.
India, Chennai
Apollo Women’s Hospital
Choi, Junyong Young
South Korea, Seoul
Yonsei Medical Research Center
Kim, Yeonsook
South Korea, Yusong
Chungnam National University, College of Medicine
Pai, Hyunjoo
South Korea, Seoul
Hanyang University Hospital
Park, Yoonsoo
South Korea, Seongnam
Gachon University
Kumar, Suresh D.
Malaysia, Sungai Buloh
Hospital Sungai Buloh
Chow, Ting Soo
Malaysia
Hospital Pulau Pinang
Crisostomo, Armando
Philippines, Manila
Philippine General Hospital
Erasmo, Alex
Philippines, Manila
University of Santo Tomas Hospital
Philippines, Manila
Jose R. Reyes Memorial Medical Center
Low, Jenny
Singapore, Singapore City
Singapore General Hospital
Basson, M. M.
South Africa, Cape Town
Tiervlei Trial Centre
Breedt, Johannes
South Africa, Pretoria
Eugene Marais Medical Village
Matthews, P. A.
South Africa, Middelburg
Middelburg Hospital
Ross, Douglas Patrick
South Africa, Durban
St. Mary's Hospital
Lin, His Hsun
Taiwan, Kaohsiung
E-da Hospital
Liao, Chun Hsing
Taiwan, New Taipei City
Far Eastern Memorial Hospital
Kung, Hsiang Chi
Taiwan, Taipei
National Taiwan University Hospital
Chinswangwatanakul, Vitoon
Thailand, Bangkok
Siriraj Hospital
Malathum, Kumthorn
Thailand, Bangkok
Ramathibodi Hospital
Tantawichien, Terapong
Thailand, Pathum Thani
Faculty of Medicine, Thammasat University
Statistics
Citations: 100
Authors: 100
Affiliations: 84
Identifiers
Doi:
10.1186/1471-2334-12-297
e-ISSN:
14712334
Study Design
Cross Sectional Study