Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis
| Autor: | Robert Maroko, Mary Beth Sabol, Nathalie Castaing, Gary Dukart, Regöly-Mérei J, John M. Embil, Jean Yan, Zsófia Ozsvár, Laszlo Lauf, Nathalie Dartois, Ismael Mitha, Angel Cooper |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Ertapenem Microbiology (medical) medicine.medical_specialty Adolescent Drug-Related Side Effects and Adverse Reactions Vomiting Nausea Population Phases of clinical research Minocycline Diabetic foot infections Tigecycline beta-Lactams Gastroenterology Young Adult chemistry.chemical_compound Vancomycin Internal medicine medicine Humans education Aged Aged 80 and over education.field_of_study business.industry Osteomyelitis General Medicine Middle Aged medicine.disease Diabetic Foot Anti-Bacterial Agents Surgery Treatment Outcome Infectious Diseases chemistry Female medicine.symptom business medicine.drug |
| Zdroj: | Diagnostic Microbiology and Infectious Disease. 78(4):469-480 |
| ISSN: | 0732-8893 |
| DOI: | 10.1016/j.diagmicrobio.2013.12.007 |
| Popis: | 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 ( |
| Databáze: | OpenAIRE |
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