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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Safety and efficacy of tigecycline in treatment of skin and skin structure infections: Results of a double-blind phase 3 comparison study with vancomycin-aztreonam
Antimicrobial Agents and Chemotherapy, Volume 49, No. 11, Year 2005
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Description
In a randomized, double-blind, controlled trial, 546 patients with complicated skin and skin structure infections received tigecycline 100 mg/day (a 100-mg initial dose and then 50 mg intravenously twice daily) or the combination of vancomycin 2 g/day (1 g intravenously twice daily) and aztreonam 4 g/day (2 g intravenously twice daily) for up to 14 days. The primary end point was the clinical response in the clinical modified intent-to-treat (c-mITT) and clinically evaluable (CE) populations at the test-of-cure visit 12 to 92 days after the last dose. The microbiologic response at the test-of-cure visit was also assessed. Safety was assessed by physical examination, laboratory results, and adverse event reporting. Five hundred twenty patients were included in the c-mITT population (tigecycline group, n = 261; combination group, n = 259), and 436 were clinically evaluable (tigecycline group, n = 223; combination group, n = 213). The clinical responses in the tigecycline and the combination vancomycin and aztreonam groups were similar in the c-mITT population (84.3% versus 86.9%; difference, -2.6% [95% confidence interval, -9.0, 3.8]; P = 0.4755) and the CE population (89.7% versus 94.4%; difference, -4.7% [95% confidence interval, -10.2, 0.8]; P = 0.1015). Microbiologic eradication (documented or presumed) occurred in 84.8% of the patients receiving tigecycline and 93.2% of the patients receiving vancomycin and aztreonam (difference, -8.5 [95% confidence interval, -16.0, -1.0]; P = 0.0243). The numbers of patients reporting adverse events were similar in the two groups, with increased nausea and vomiting rates in the tigecycline group and an increased incidence of rash and increases in alanine aminotransferase and aspartate aminotransferase levels in the combination vancomycin and aztreonam group. Tigecycline was shown to be safe and effective for the treatment of complicated skin and skin structure infections. Copyright © 2005, American Society for Microbiology. All Rights Reserved.
Authors & Co-Authors
Breedt, Johannes
South Africa, Pretoria
Eugene Marais Hospital
Teras, Jüri
Estonia, Tallinn
North Estonian Regional Hospital
Gardovskis, Janis
Latvia, Riga
Paula Stradina Clinical University Hospital
Maritz, Frans Jacobus
South Africa, Stellenbosch
Stellenbosch University
Vaasna, Tiit
Estonia, Tartu
Tartu University Clinics
Ross, Douglas Patrick
South Africa, Durban
St. Mary's Hospital
Gioud-Paquet, Martine
France, Paris
Wyeth Research
Dartois, Nathalie
France, Paris
Wyeth Research
Ellis-Grosse, Evelyn J.
United States, New York
Pfizer Inc.
Loh, Evan
United States, New York
Pfizer Inc.
Statistics
Citations: 190
Authors: 10
Affiliations: 8
Identifiers
Doi:
10.1128/AAC.49.11.4658-4666.2005
ISSN:
00664804
Research Areas
Disability
Study Design
Cross Sectional Study
Cohort Study