Literature DB >> 18545153

A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis.

José A Vazquez1, Jennifer A Schranz, Kay Clark, Beth P Goldstein, Annette Reboli, Carl Fichtenbaum.   

Abstract

BACKGROUND: Azole-refractory mucosal candidiasis is a debilitating disease frequently seen in patients who are immunosuppressed as a result of HIV, malignancy, posttransplant immunosuppressive therapy, persistent neutropenia, steroid use, or diabetes. Anidulafungin has potent activity against a broad spectrum of Candida species, including strains resistant to azoles and amphotericin B. We performed an open-label, noncomparative study to examine efficacy and safety of anidulafungin in patients with azole-refractory oropharyngeal and esophageal candidiasis.
METHODS: Patients enrolled met diagnostic criteria for azole-refractory mucosal candidiasis. They received intravenous anidulafungin 100 mg on day 1 followed by daily 50-mg doses on day 2 through day 14 or for a maximum of 21 days. Primary efficacy variables were clinical response (for oropharyngeal candidiasis) and endoscopic and clinical response (for esophageal candidiasis) at the end of therapy.
RESULTS: Nineteen patients were enrolled; 89% had advanced HIV infection. Clinical success was observed in 95% of patients at end of therapy, and endoscopic success was observed in 92% of patients with esophageal candidiasis. At follow-up, clinical success was maintained in 47% of patients. The most common adverse event, experienced by 4 patients, was nausea and/or vomiting.
CONCLUSIONS: Anidulafungin was well tolerated and efficacious in the treatment of patients with azole-refractory esophageal and oropharyngeal candidiasis.

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Year:  2008        PMID: 18545153     DOI: 10.1097/QAI.0b013e31817af47a

Source DB:  PubMed          Journal:  J Acquir Immune Defic Syndr        ISSN: 1525-4135            Impact factor:   3.731


  10 in total

1.  Conclusions. Anidulafungin is a new echinocandin developed for more effective treatment of serious systemic fungal infections.

Authors:  Pasquale De Bellis
Journal:  Drugs       Date:  2009       Impact factor: 9.546

Review 2.  Echinocandin antifungal drugs in fungal infections: a comparison.

Authors:  Sharon C-A Chen; Monica A Slavin; Tania C Sorrell
Journal:  Drugs       Date:  2011-01-01       Impact factor: 9.546

Review 3.  Pharmacokinetics, antifungal activity and clinical efficacy of anidulafungin in the treatment of fungal infections.

Authors:  Effie L Kuti; Joseph L Kuti
Journal:  Expert Opin Drug Metab Toxicol       Date:  2010-10       Impact factor: 4.481

4.  Population pharmacokinetic-pharmacodynamic analysis of anidulafungin in adult patients with fungal infections.

Authors:  Ping Liu
Journal:  Antimicrob Agents Chemother       Date:  2012-11-05       Impact factor: 5.191

Review 5.  Pediatric antifungal agents.

Authors:  Michael Cohen-Wolkowiez; Cassandra Moran; Daniel K Benjamin; Phillip B Smith
Journal:  Curr Opin Infect Dis       Date:  2009-12       Impact factor: 4.915

Review 6.  The use of antifungal therapy in neonatal intensive care.

Authors:  Daniela Testoni; P Brian Smith; Daniel K Benjamin
Journal:  Clin Perinatol       Date:  2012-01-11       Impact factor: 2.642

7.  Anidulafungin: an evidence-based review of its use in invasive fungal infections.

Authors:  Susan L Davis; Jose A Vazquez
Journal:  Core Evid       Date:  2008-07-31

8.  Anidulafungin and its role in candida infections.

Authors:  Diane M Cappelletty; Rose Jung
Journal:  Infect Drug Resist       Date:  2009-06-30       Impact factor: 4.003

9.  Therapy and prophylaxis of opportunistic infections in HIV-infected patients: a guideline by the German and Austrian AIDS societies (DAIG/ÖAG) (AWMF 055/066).

Authors:  J Thoden; A Potthoff; J R Bogner; N H Brockmeyer; S Esser; K Grabmeier-Pfistershammer; B Haas; K Hahn; G Härter; M Hartmann; C Herzmann; J Hutterer; A R Jordan; C Lange; S Mauss; D Meyer-Olson; F Mosthaf; M Oette; S Reuter; A Rieger; T Rosenkranz; M Ruhnke; B Schaaf; S Schwarze; H J Stellbrink; H Stocker; A Stoehr; M Stoll; C Träder; M Vogel; D Wagner; C Wyen; C Hoffmann
Journal:  Infection       Date:  2013-09-14       Impact factor: 3.553

10.  Evaluation of an early step-down strategy from intravenous anidulafungin to oral azole therapy for the treatment of candidemia and other forms of invasive candidiasis: results from an open-label trial.

Authors:  Jose Vazquez; Annette C Reboli; Peter G Pappas; Thomas F Patterson; John Reinhardt; Peter Chin-Hong; Ellis Tobin; Daniel H Kett; Pinaki Biswas; Robert Swanson
Journal:  BMC Infect Dis       Date:  2014-02-21       Impact factor: 3.090

  10 in total

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