Phase 2
Completed N=40
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
Source: ClinicalTrials.gov NCT00739934 ↗Enrolled (actual)
40
Serious AEs
25.7%
Results posted
Jan 2011
Primary outcomePrimary: Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration — 21.42 μg*h/mL
Summary
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration |
21.42 | — |
| PRIMARY Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration |
4.26 | — |
| PRIMARY Time to Reach Cmax (Tmax) Following IV Administration |
2.30 | — |
| PRIMARY AUC12,ss Following Oral Administration |
18.64 | — |
| PRIMARY Cmax,ss Following Oral Administration |
3.62 | — |
| PRIMARY Tmax Following Oral Administration |
1.07 | — |
| SECONDARY AUC12 Following IV Loading Dose |
7.85 | — |
| SECONDARY Cmax Following an IV Loading Dose |
2.15 | — |
| SECONDARY Tmax Following an IV Loading Dose |
2.30 | — |
| SECONDARY Trough Concentrations (Cmin) |
0.61; 0.52 | — |
| SECONDARY AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
20.98; 41.95 | — |
| SECONDARY Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
2.97; 4.47 | — |
| SECONDARY Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
4.00; 4.00 | — |
| SECONDARY AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
51.65 | — |
| SECONDARY Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
5.62 | — |
| SECONDARY Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
3.97 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female from 2 to <12 years of age.
- Require treatment for the prevention of systemic fungal infection.
- Expected to develop neutropenia (ANC <500 cells/μL) lasting more than 10 days following chemotherapy.
- Anticipated to live for more than 3 months.
Exclusion Criteria
- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
- Documented bacterial or viral infection not responding to appropriate treatment.
- Hypersensitivity to or severe intolerance of azole antifungal agents.
- Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
Data sourced from ClinicalTrials.gov (NCT00739934). 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.