Abstract
The incidence of nosocomial invasive fungal infections involving Candida spp. has increased markedly in recent years in patients undergoing abdominal surgery. This post hoc analysis aimed to determine the efficacy and safety of anidulafungin treatment in patients with intra-abdominal candidiasis (IAC) from five prospective studies (one comparative and four open-label) of adult surgical patients with microbiologically confirmed Candida intra-abdominal infection. Patients received an intravenous (IV) loading dose of anidulafungin 200 mg, followed by a daily 100-mg maintenance dose. Per study protocols, some patients could be switched to an oral azole after ≥ 5 or ≥ 10 days of IV treatment. Antifungal treatment was maintained for ≥ 14 days after the last positive Candida culture and resolution of symptoms. The global response rate (GRR) at the end of IV treatment (EOIVT) was the primary endpoint. GRR at the end of therapy (EOT), all-cause mortality at days 14 and 28, and safety was also evaluated. Seventy-nine patients had IAC from peritoneal fluid or hepatobiliary tract. C. albicans (72.2%) and C. glabrata (32.9%) were the most common pathogens. Overall GRR was 73.4% and 67.1% at EOIVT and EOT, respectively. All-cause mortality was 17.7% at day 14 and 24.1% at day 28 in the modified intent-to-treat population. Anidulafungin was well tolerated in this population, with most adverse events mild or moderate in severity. In these patients with IAC, anidulafungin showed a GRR at EOIVT similar to the anidulafungin registrational trial, and the results of our analysis confirmed the known safety profile of anidulafungin. ClinicalTrials.gov registration number NCT00496197, registered July 3, 2007, https://clinicaltrials.gov/ct2/show/study/NCT00496197; ClinicalTrials.gov registration number NCT00548262, registered October 19, 2007, https://clinicaltrials.gov/ct2/show/record/NCT00548262; ClinicalTrials.gov registration number NCT00537329, registered September 25, 2007, https://clinicaltrials.gov/ct2/show/record/NCT00537329; ClinicalTrials.gov registration number NCT00689338, registered May 29, 2008, https://clinicaltrials.gov/ct2/show/study/NCT00689338; ClinicalTrials.gov registration number NCT00805740, registered November 26, 2008, https://clinicaltrials.gov/ct2/show/NCT00805740
Highlights
The incidence of nosocomial invasive fungal infections involving Candida species has increased in recent years because of the increasing number of immunocompromised patients, including patients with cancer, patients undergoing transplants, patients with human immunodeficiency virus and patients in intensive care units (ICUs) [1,2,3,4].Clinical data on intra-abdominal candidiasis (IAC) are still scarce, IAC is a common type of invasive candidiasis following candidaemia [5]
Another study demonstrated that C. albicans was cultured in 11/18 cases in a bariatric surgery group and in 23/46 cases in a conventional surgery group, whereas C. glabrata was cultured in 13/46 cases in the conventional surgery group and 3/6 cases were resistant to fluconazole [14]
A recent, prospective, single-centre, population-based study in a surgical ICU setting observed that IAC was a frequent form of invasive candidiasis (13/22 episodes in 1149 patients) and that antifungal therapy and good source control led to a good outcome
Summary
The incidence of nosocomial invasive fungal infections involving Candida species has increased in recent years because of the increasing number of immunocompromised patients, including patients with cancer, patients undergoing transplants, patients with human immunodeficiency virus and patients in intensive care units (ICUs) [1,2,3,4]. Previous studies have demonstrated the predominance of C. albicans isolates (approximately 75%), followed by C. glabrata, in intra-abdominal Candida infections in surgical patients [9, 10]. In patients admitted to ICUs with post-operative peritonitis, multidrug-resistant strains were frequent and increased with the number of reoperations for persistent abdominal sepsis [12]. A recent, prospective, single-centre, population-based study in a surgical ICU setting observed that IAC was a frequent form of invasive candidiasis (13/22 episodes in 1149 patients) and that antifungal therapy and good source control led to a good outcome. Among the echinocandin class of antifungal agents, anidulafungin is a cyclic lipopeptide approved for the treatment of candidaemia and other forms of invasive candidiasis such as intra-abdominal abscesses and peritonitis.
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