Phase 3
Completed N=70
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Source: ClinicalTrials.gov NCT00761267 ↗Enrolled (actual)
70
Serious AEs
44.1%
Results posted
Sep 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 17; 19; 30; 7 Participants
◆ Published Evidence
Established
37citations · ~6 / year
Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age With Invasive Candidiasis, Including Candidemia.
Summary
Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - <18 years) with invasive candidiasis, including candidemia (ICC).
Linked Publications (2)
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Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age With Invasive Candidiasis, Including Candidemia.
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A Prospective, Open-label Study to Assess the Safety, Tolerability and Efficacy of Anidulafungin in the Treatment of Invasive Candidiasis in Children 2 to <18 Years of Age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
17; 19; 30; 7; 10; 13 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities |
19; 18; 30 | — |
| SECONDARY Number of Participants With Global Response |
11; 14; 20; 2; 1; 3 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup |
66449.1 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup |
5963.53 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup |
NA | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup |
NA | — |
| SECONDARY Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin |
69.87; 82.81; 86.77 | — |
| SECONDARY Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin |
1.98; 2.51; 2.52 | — |
| SECONDARY Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) |
1; 3; 5; 1; 2 | — |
| SECONDARY Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) |
5; 10; 6; 4; 2 | — |
| SECONDARY Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) |
100; 93.33; 77.78; 87.5; 85.71; 0 | — |
| SECONDARY Percentage of Participants With Relapsed Response |
0.0; 0.0; 0.0; 0.0; 5.6; 6.7 | — |
| SECONDARY Percentage of Participants With New Infection |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits |
0; 1; 4; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must be either (1) at high risk for candidiasis (1 month - < 2 years ONLY) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups)
- Male and female patients from 1 month to less than 18 years of age.
Exclusion Criteria
- Any patients with allergy to the drug; and any pregnant female or lactating.
- Failed previous antifungal therapy or expected to live < 3 days.
- Patients with documented or suspected Candida meningitis.
Data sourced from ClinicalTrials.gov (NCT00761267) and the linked publication. 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.