1. An open-label study of anidulafungin for the treatment of candidaemia/invasive candidiasis in Latin America.
- Author
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Nucci, Marcio, Colombo, Arnaldo L., Petti, Marco, Magana, Martin, Abreu, Paula, Schlamm, Haran T., and Sanchez, Sonia P.
- Subjects
CANDIDIASIS ,MORTALITY ,ABDOMINAL surgery - Abstract
Incidence and mortality of candidaemia/invasive candidiasis (C/ IC) is relatively high in Latin America versus North America and Europe. To assess efficacy and safety of intravenous ( IV) anidulafungin in Latin American adults with documented C/ IC. All patients in this open-label study received initial IV anidulafungin with optional step-down to oral voriconazole after 5 days; total treatment duration was 14-42 days. The primary endpoint was global response (clinical + microbiological response) at end of treatment ( EOT); missing/indeterminate responses were failures. The study enrolled 54 patients; 44 had confirmed C/ IC within 96 h before study entry and comprised the modified intent-to-treat population. Global response at EOT was 59.1% (95% CI: 44.6, 73.6), with 13 missing/indeterminate assessments. Thirty-day all-cause mortality was 43.1%. Fourteen patients (31.8%) were able to step-down to oral voriconazole; these patients had lower baseline acute physiological assessment and chronic health evaluation ( APACHE) II scores and were less likely to have solid tumours or previous abdominal surgery. Anidulafungin was generally well tolerated with few treatment-related adverse events. Anidulafungin was associated with relatively low response rates influenced by a high rate of missing/indeterminate assessments and mortality comparable to other recent candidaemia studies in Latin America. In a subset of patients with lower APACHE II scores, short-course anidulafungin followed by oral voriconazole was successful. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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