Anidulafungin PK in Infants and Toddlers

NCT00734500 | Completed Phase 1 Results

• 1 other identifier: Pro00000637
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Fungal Infections

Outcome Measures

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.

  Area under the curve at steady state

  5 days

Secondary Outcomes (1)

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

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

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment

Drug: Anidulafungin

Interventions

Anidulafungin DRUG

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

Also known as: Eraxis

Treatment

Eligibility Criteria

• Age: 48 Hours - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Cohen-Wolkowiez: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Michael Cohen-Wolkowiez
• Organization: Duke University

michael.cohenwolkowiez@duke.edu

9196688812

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 21, 2012
• Results First Posted: December 14, 2011

Record last verified: 2012-11

Locations

US (1)