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A prospective, multicenter study of caspofungin for the treatment of documented Candida or Aspergillus infections in pediatric patients.
Zaoutis, Theoklis E; Jafri, Hasan S; Huang, Li-Min; Locatelli, Franco; Barzilai, Asher; Ebell, Wolfram; Steinbach, William J; Bradley, John; Lieberman, Jay M; Hsiao, Chih-Cheng; Seibel, Nita; Laws, Hans-Juergen; Gamba, Melinda; Petrecz, Maria; Taylor, Arlene F; Strohmaier, Kim M; Chow, Joseph W; Kartsonis, Nicholas A; Ngai, Angela L.
  • Zaoutis TE; Children's Hospital of Philadelphia, Division of Infectious Diseases, 34th Street and Civic Center Boulevard, CHOP North, Suite 1527, Philadelphia, PA 19104, USA. zaoutis@email.chop.edu
Pediatrics ; 123(3): 877-84, 2009 Mar.
Article en En | MEDLINE | ID: mdl-19255017
ABSTRACT

OBJECTIVE:

We evaluated the safety, tolerability, and efficacy of caspofungin in pediatric patients with invasive aspergillosis, invasive candidiasis, or esophageal candidiasis.

METHODS:

This was a multicenter, prospective, open-label study in children 3 months to 17 years of age with proven or probable invasive aspergillosis, proven invasive candidiasis, or proven esophageal candidiasis. All of the patients received caspofungin 70 mg/m(2) on day 1, followed by 50 mg/m(2) per day (maximum 70 mg/day), as primary or salvage monotherapy. Favorable response was defined as complete resolution of clinical findings and microbiologic (or radiographic/endoscopic) eradication (complete response) or significant improvement in these parameters (partial response). Efficacy was assessed at the end of caspofungin therapy in patients with a confirmed diagnosis who received >/=1 dose of caspofungin. The primary safety evaluation was the proportion of patients with clinical or laboratory drug-related adverse events.

RESULTS:

Of the 49 patients enrolled, 3 were <2 years of age, 30 were 2 to 11 years of age, and 16 were 12 to 17 years of age. Forty-eight patients had confirmed disease invasive aspergillosis (10), invasive candidiasis (37), and esophageal candidiasis (1). Eight of 10 patients with invasive aspergillosis had pulmonary involvement; 34 of 37 patients with invasive candidiasis had candidemia. Caspofungin was given for 2 to 87 days. Success at end of therapy was achieved in 5 of 10 patients with invasive aspergillosis, 30 of 37 with invasive candidiasis, and 1 of 1 with esophageal candidiasis. One patient (invasive candidiasis) relapsed during the 28-day follow-up period. Drug-related clinical or laboratory adverse events occurred in 27% and 35% of patients, respectively. There were no serious drug-related adverse events or discontinuations of caspofungin because of toxicity.

CONCLUSIONS:

Caspofungin was generally well tolerated in pediatric patients aged 6 months through 17 years. Efficacy outcomes in patients with invasive aspergillosis or invasive candidiasis were consistent with previous adult studies in these indications.
Asunto(s)

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Aspergilosis / Infecciones Oportunistas / Candidiasis / Enfermedades del Esófago / Equinocandinas / Aspergilosis Pulmonar / Antifúngicos Tipo de estudio: Clinical_trials / Observational_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Año: 2009 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Aspergilosis / Infecciones Oportunistas / Candidiasis / Enfermedades del Esófago / Equinocandinas / Aspergilosis Pulmonar / Antifúngicos Tipo de estudio: Clinical_trials / Observational_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Año: 2009 Tipo del documento: Article