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Anidulafungin PK in Infants and Toddlers

Information source: Duke University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Fungal Infections

Intervention: Anidulafungin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Michael Cohen-Wolkowiez

Summary

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.

Clinical Details

Official title: Anidulafungin PK in Infants and Toddlers

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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

Eligibility

Minimum age: N/A. Maximum age: 24 Months. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Duke University, Durham, North Carolina 27705, United States
Additional Information

Starting date: January 2008
Last updated: November 16, 2012

Page last updated: August 20, 2015

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