Phase 1
Completed N=15
Anidulafungin PK in Infants and Toddlers
Source: ClinicalTrials.gov NCT00734500 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Dec 2011
Primary outcomePrimary: The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. — 84 µg*h/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. |
84 | — |
| SECONDARY Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. |
8 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00734500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.