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Completed

NCT Number: NCT00734500

Anidulafungin PK in Infants and Toddlers

This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Mycoses

Age range

48 hour–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age < 24 months at the time of enrollment
  • Patient must have sufficient venous access to permit administration of study medication
  • Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
  • Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion criteria

  • Patients with a history of anaphylaxis attributed to an echinocandin
  • Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
  • Previous participation in this study
  • Previous exposure to an echinocandin in the month prior to study.

Treatment and study plan

Anidulafungin

Drug

Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.

Other names: Eraxis

Primary outcomes

  1. The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.

    Time frame: 5 days

    Area under the curve at steady state

Secondary outcomes

  1. Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.

    Time frame: During and up to 10 days after last dose of study drug.

    Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.

Sponsors and collaborators

Lead sponsor

Michael Cohen-Wolkowiez

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Nov 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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