Phase 2
N=21
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
Aspergillosis, Aspergilloma
Bottom Line
View on ClinicalTrials.gov: NCT01383993 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration — 51.92; 83.39; 17.27 μg*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Voriconazole (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration |
51.92; 83.39; 17.27 | — |
| PRIMARY Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration |
7.753; 9.233; 3.092 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration |
2.96; 4.00; 1.34 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration |
48.23; 59.42; 10.00 | — |
| PRIMARY Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration |
7.755; 7.910; 2.030 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration |
1.09; 1.00; 1.00 | — |
| PRIMARY Number of Participants Assessed Near Distance Visual Acuity Test |
18; 18; 17; 15; 14 | — |
| PRIMARY Number of Participants Assessed Color Vision Test |
19; 18; 17; 15; 14 | — |
| PRIMARY Number of Participants Assessed Visual Questionnaire |
19; 18; 17; 15; 14 | — |
| SECONDARY Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration |
1.077; 0.648; 0.476 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
66.50; 80.99; 40.00 | — |
| SECONDARY Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
6.381; 8.066; 3.835 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
5.05; 4.49; 3.84 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
79.86; 90.84; 34.40 | — |
| SECONDARY Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
7.971; 8.912; 3.720 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
2.07; 2.03; 3.80 | — |
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 less than 15 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.
Eligibility Criteria
Inclusion Criteria
- Male or female from 2 to <15 years of age.
- Require treatment for the prevention of systemic fungal infection.
- Expected to develop neutropenia (ANC <500 cells/uL) 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 (NCT01383993). 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.