Micafungin for the treatment of proven and suspected invasive candidiasis in children and adults: findings from a multicenter prospective observational study

BMC Infectious Diseases

Daniele Roberto Giacobbe¹  Carlo Tascini⁴  Sandra Ratto¹  Francesco Menichetti⁴  Simone Cesaro²  Elio Castagnola³  Matteo Bassetti⁵  Claudio Viscoli¹ 

[1] Infectious Diseases Unit, IRCCS San Martino University Hospital – IST, University of Genoa, L.go R. Benzi, Genoa, 10-16132, Italy;Paediatric Hematology Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, P.le L.A. Scuro, Verona, 10-37134, Italy;Infectious Disease Unit, Istituto Giannina Gaslini, Largo G.Gaslini, Genoa, 5-16147, Italy;U.O.C. Malattie Infettive, Azienda Ospedaliera Universitaria Pisana, Via Paradisa, Cisanello, 2 – 56100, Pisa, Italy;Infectious Diseases Division, Santa Maria Misericordia Hospital, Piazzale Santa Maria della Misericordia, Udine, 15-33100, Italy

关键词: Post marketing surveillance;    Candidemia;    Invasive candidiasis;    Clinical response;    Safety;    Micafungin;   

Others  :  1090024
DOI  :  10.1186/s12879-014-0725-7

 received in 2014-07-15, accepted in 2014-12-17,  发布年份 2014

【 摘 要 】

Background

A multicenter observational study was conducted in Italy to assess the safety of micafungin in the daily clinical practice for the treatment of proven and suspected invasive candidiasis (IC), as well as to describe rates of clinical response to micafungin treatment.

Methods

From October 2010 to March 2012, data from consecutive eligible neonate, pediatric, and adult patients treated with micafungin for a proven or suspected IC were collected. Patients were deemed as eligible if they or their parents signed an informed consent. The study endpoints were to assess safety of micafungin in the treatment of both proven and suspected IC, and to describe rates of clinical response to micafungin treatment. Clinical response was assessed at the end of micafungin treatment (EOMT) and defined as favorable (complete or partial resolution of signs and symptoms) or unfavorable (stability or progression).

Results

During the study period, 108 patients with proven or suspected IC were enrolled. Thirty-six out of 108 patients (33%) were < 18 year-old (median 1 year), whereas 72 (67%) were ≥ 18 year-old (median 71 years). Neonates in NICU accounted for 36% of pediatric patients, with the majority of them (54%) being extremely low birth weight (ELBW) newborns. Fifty-eight out of 108 patients (54%) received micafungin for a proven IC, whereas 50/108 patients (46%) were treated for a suspected IC. Among proven IC, candidemia accounted for the majority of events (54/58, 93%), with Candida albicans (35/58, 60%) as the most frequently isolated species. Therapy was discontinued due to occurrence of an adverse event in 4/108 subjects (4%). No pediatric patient had treatment interruption because of adverse events. A 67% favorable response rate was observed at EOMT. No age-, species-, underlying conditions- or ward-related differences of favorable response were observed. Survival at EOMT was 90% (97/108 patients), with rates of 97% (35/36) and 86% (62/72) among children and adults, respectively.

Conclusions

Micafungin was well tolerated in a heterogeneous real world population with a bimodal age distribution. A high rate of favorable response to micafungin treatment was reported in both proven and suspected IC.

【 授权许可】

   
2014 Viscoli et al.; licensee BioMed Central.

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