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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis
Diagnostic Microbiology and Infectious Disease, Volume 78, No. 4, Year 2014
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Description
A phase 3, randomized, double-blind trial was conducted in subjects with diabetic foot infections without osteomyelitis (primary study) or with osteomyelitis (substudy) to determine the efficacy and safety of parenteral (intravenous [iv]) tigecycline (150 mg once-daily) versus 1 g once-daily iv ertapenem ± vancomycin. Among 944 subjects in the primary study who received ≥1 dose of study drug, >85% had type 2 diabetes; ~90% had Perfusion, Extent, Depth/tissue loss, Infection, and Sensation infection grade 2 or 3; and ~20% reported prior antibiotic failure. For the clinically evaluable population at test-of-cure, 77.5% of tigecycline- and 82.5% of ertapenem ± vancomycin-treated subjects were cured. Corresponding rates for the clinical modified intent-to-treat population were 71.4% and 77.9%, respectively. Clinical cure rates in the substudy were low (<36%) for a subset of tigecycline-treated subjects with osteomyelitis. Nausea and vomiting occurred significantly more often after tigecycline treatment (P = 0.003 and P < 0.001, respectively), resulting in significantly higher discontinuation rates in the primary study (nausea P = 0.007, vomiting P < 0.001). In the primary study, tigecycline did not meet criteria for noninferiority compared with ertapenem ± vancomycin in the treatment of subjects with diabetic foot infections. © 2014 The Authors.
Authors & Co-Authors
Lauf, Laszlo
Hungary, Budapest
Buda Hospital of the Hospitaller Order of Saint John of God
Ozsvár, Zsófia
Hungary, Szekesfehervar
St. George's Hospital
Mitha, Ismail Haroon
South Africa, Johannesburg
Benmed Hospital
Regöly-Mérei, Janos
Hungary, Budapest
Semmelweis Egyetem
Embil, John M.
Canada, Winnipeg
University of Manitoba
Cooper, Angel
United States, New York
Pfizer Inc.
Sabol, Mary Elizabeth
United States, New York
Pfizer Inc.
Castaing, Nathalie
United States, New York
Pfizer Inc.
Dartois, Nathalie
United States, New York
Pfizer Inc.
Yan, Jean
United States, New York
Pfizer Inc.
Dukart, Gary
United States, New York
Pfizer Inc.
Maroko, Robert T.
United States, New York
Pfizer Inc.
Statistics
Citations: 63
Authors: 12
Affiliations: 6
Identifiers
Doi:
10.1016/j.diagmicrobio.2013.12.007
ISSN:
07328893
Research Areas
Disability
Noncommunicable Diseases
Study Design
Cross Sectional Study