Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005912
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-06-14
Brief Title:
Voriconazole to Prevent Systemic Fungal Infections in Children
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Open Intravenous Multiple Dose Multi-Center Study to Investigate the Pharmacokinetics Safety and Toleration of Voriconazole in Children Aged 2-12 Years Who Require Treatment for the Prevention of Systemic Fungal Infection
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine how childrens bodies metabolize and eliminate the anti-fungal drug voriconazole The results will yield information needed to make recommendations for safe and effective dosing of the drug in children Children with reduced immune function-such as those receiving drugs for cancer treatment-are at high risk for serious fungal infections
Children between 2 and 12 years old who need treatment to prevent fungal infections may be eligible for this study Candidates will be screened with a physical examination eye examination and blood and urine tests
Children in the study will be hospitalized for 21 days They will receive voriconazole twice a day every 12 hours for 8 days infused through a vein over a period of 1 to 2 hours The dose will be determined based on the individual childs weight Blood samples will be collected at various intervals before and after the infusions on days 1 2 4 and 8 to determine the amount of drug in the blood On day 8 the child will have another physical and eye examination as well as additional blood and urine tests If additional treatment is required voriconazole may be continued for up to day 21 Children who require the drug for more than 21 days may receive it under another research protocol On the last day of treatment the child will have another physical examination and blood and urine tests These procedures will be repeated again at 30 to 35 days following the last dose of drug A small sample of blood will also be analyzed for genetic information related to the rate of metabolism of voriconazole-that is how fast or slow it is cleared eliminated by the liver
Voriconazole is effective against several different fungi It may protect children against serious fungal infections with fewer side effects than standard available therapy
Children between 2 and 12 years old who need treatment to prevent fungal infections may be eligible for this study Candidates will be screened with a physical examination eye examination and blood and urine tests
Children in the study will be hospitalized for 21 days They will receive voriconazole twice a day every 12 hours for 8 days infused through a vein over a period of 1 to 2 hours The dose will be determined based on the individual childs weight Blood samples will be collected at various intervals before and after the infusions on days 1 2 4 and 8 to determine the amount of drug in the blood On day 8 the child will have another physical and eye examination as well as additional blood and urine tests If additional treatment is required voriconazole may be continued for up to day 21 Children who require the drug for more than 21 days may receive it under another research protocol On the last day of treatment the child will have another physical examination and blood and urine tests These procedures will be repeated again at 30 to 35 days following the last dose of drug A small sample of blood will also be analyzed for genetic information related to the rate of metabolism of voriconazole-that is how fast or slow it is cleared eliminated by the liver
Voriconazole is effective against several different fungi It may protect children against serious fungal infections with fewer side effects than standard available therapy
Detailed Description:
The objective of this study is to evaluate the serum levels and pharmacokinetic parameters achieved following two dosage levels of voriconazole In addition the safety and toleration of intravenous voriconazole at two dosage levels in an immunocompromised pediatric patient population will be evaluated Also the plasma concentrations of the major metabolite of voriconazole N-oxide in these patients will be performed The study is designed as a multi-center open label multi-dose study of intravenous voriconazole Intravenous voriconazole will be administered prophylactically twice daily to immunocompromised children at high risk for invasive mycoses The patient population consists of children ages 2 years to 12 years of age two age groups will be studied 2-6 6-12 Initial dosage levels will be 3mgkg q12h and 4mgkg q12h The planned sample size is 24 children For those children who do not complete the full 8 days of kinetics a replacement patient will be added Immunocompromised children at high risk for invasive mycoses will receive voriconazole prophylactically Therapy will be initiated within 48 hours after completion of chemotherapy Voriconazole therapy will continue until recovery from neutropenia The first 12 children will initially receive a loading dose of 6mgkg X 2 doses followed by 3mgkg BID through day 4 of therapy Twelve hour pharmacokinetics will be collected on day 4 Children will then receive 4mgkg starting on the second dose of day 4 and will continue at that dosage level until recovery from neutropenia Kinetics will again be collected at the 4mgkg dosage level on day 8 of therapy If the mean peak plasma concentration of voriconazole in the first 12 patients following 4mgkg q12h dosing is less than 4000ngml the remaining 12 patients will receive voriconazole after day 4 at a dosage of 5mgkg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0150 | None | None | None |