Published online March 2, 2009
PEDIATRICS Vol. 123 No. 3 March 2009, pp. 877-884 (doi:10.1542/peds.2008-1158)

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services E-mail this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Zaoutis, T. E. Articles by Ngai, A. L. Search for Related Content PubMed PubMed Citation Articles by Zaoutis, T. E. Articles by Ngai, A. L. Related Collections Infectious Disease & Immunity Related AAP Red Book topics: Candidiasis (Moniliasis, Thrush) Aspergillosis Social Bookmarking                         What's this?

ARTICLE

A Prospective, Multicenter Study of Caspofungin for the Treatment of Documented Candida or Aspergillus Infections in Pediatric Patients

Theoklis E. Zaoutis, MD, MSCE^a, Hasan S. Jafri, MD^b, Li-Min Huang, MD^c, Franco Locatelli, MD^d, Asher Barzilai, MD^e, Wolfram Ebell, MD^f, William J. Steinbach, MD^g, John Bradley, MD^h, Jay M. Lieberman, MDⁱ, Chih-Cheng Hsiao, MD^j, Nita Seibel, MD^k, Hans-Juergen Laws, MD^l, Melinda Gamba, MS^m, Maria Petrecz, BSBA^m, Arlene F. Taylor, MS^m, Kim M. Strohmaier, BS^m, Joseph W. Chow, MD^m, Nicholas A. Kartsonis, MD^m and Angela L. Ngai, BS^m

^a Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
^b Division of Infectious Diseases, University of Texas Southwestern Medical Center, Dallas, Texas
^c Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan
^d Fondazione, Istituto Di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, University of Pavia, Pavia, Italy
^e Pediatric Infectious Disease Unit, Chaim Sheba Medical Center, Tel Hashomer, Israel
^f Department of Pediatrics, University Charite, Berlin, Germany
^g Division of Infectious Diseases, Duke University, Durham, North Carolina
^h Division of Infectious Diseases, Children's Hospital and Health Center, San Diego, California
ⁱ Division of Pediatric Infectious Diseases, University of California, Irvine, California
^j Department of Pediatrics, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan
^k Division of Oncology, Children's National Medical Center, Washington, DC
^l Department of Paediatric Oncology, Haematology and Immunology, Heinrich-Heine University Medical Center, Dusseldorf, Germany
^m Clinical Research, Infectious Diseases, Merck Research Laboratories, West Point, Pennsylvania

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/m² on day 1, followed by 50 mg/m² 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.

---

Key Words: caspofungin • echinocandin • invasive aspergillosis • invasive candidiasis • pediatric patients

Abbreviations: ULN—upper limit of normal • AST—aspartate aminotransferase • ALT—alanine aminotransferase • CI—confidence interval • CNS—central nervous system • MIC—minimum inhibitory concentration • ABLC—amphotericin B lipid complex

---

Accepted Jun 18, 2008.

CiteULike    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?