Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059592
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2003-04-29
Brief Title:
Valacyclovir in Immunocompromised Children
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Valacyclovir in Immunocompromised Children
Status:
COMPLETED
Status Verified Date:
2020-03
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:
Shingles is an infection commonly seen in children with a weakened immune system immunocompromised children The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation Shingles in children with a weakened immune system may spread throughout the body and in some instances may be life-threatening Acyclovir is a medication that is routinely used to treat immunocompromised children with shingles in order to prevent further spread of their shingles and to help them heal faster Acyclovir is also given to bone marrow transplant patients to prevent reactivation of HSV infection
Valacyclovir is a new drug that is metabolized broken down in the body to acyclovir Valacyclovir is given by mouth and studies done in adults have shown it to be more effective than acyclovir given by mouth
The purpose of this study is to
study the pharmacology of this drug how the body handles this drug
determine if oral Valacyclovir can be safely given to children with shingles and
determine the type of side effects that occur when oral Valacyclovir is given to immunocompromised children
Valacyclovir is a new drug that is metabolized broken down in the body to acyclovir Valacyclovir is given by mouth and studies done in adults have shown it to be more effective than acyclovir given by mouth
The purpose of this study is to
study the pharmacology of this drug how the body handles this drug
determine if oral Valacyclovir can be safely given to children with shingles and
determine the type of side effects that occur when oral Valacyclovir is given to immunocompromised children
Detailed Description:
Patients with shingles
Patients with shingles will receive oral Valacyclovir three times a day for 5 to 10 days For the first 24 hours of treatment patients will be admitted to the hospital for close monitoring If there are no problems after the first 24 hours then the patient may be discharged to take the medicine at home
After discharge patients will be seen and examined in clinic daily for the first 5 days then on day 7 and after that every other day until the shingles show evidence of healing A final physical exam and blood tests occur on day 21
A small amount of fluid will be taken from one of the shingles lesions using a very fine needle to verify the presence of the virus that causes shingles This will be done before the first dose of Valacyclovir and 3 days later
Blood tests no more than 2 teaspoons will be performed twice a week to monitor for toxic effects of the drug Blood samples will be drawn to evaluate the pharmacology of this drughow the body handles the drug Nine blood samples less than one teaspoon each will be obtained over 24 hours during the first day of treatment The total amount of blood to be drawn is 9 teaspoons 3 tablespoons
For children that are toilet trained urine will be collected for 12 hours at the start of the study This urine will be used to evaluate kidney function and the pharmacology of valacyclovir If there are unacceptable side effects or if there is evidence that the disease is spreading despite being on Valacyclovir for more than 48 hours then you will be taken off the study and started on acyclovir by vein
Patients Undergoing Bone Marrow Transplantation
Patients undergoing a bone marrow transplant will receive a single dose of valacyclovir in place of their first scheduled dose of acyclovir They will then receive acyclovir as outlined by their physician
Blood samples will be drawn to evaluate the pharmacology how the body handles the drug of the study drug Fifteen blood samples less than one teaspoon each will be obtained over 24 hours during the first day of treatment The total amount of blood to be drawn is 9 teaspoons 3 tablespoons The total amount of blood drawn for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5 of the patients total blood volume This amount of blood loss is a safe amount even for small children
Patients with shingles will receive oral Valacyclovir three times a day for 5 to 10 days For the first 24 hours of treatment patients will be admitted to the hospital for close monitoring If there are no problems after the first 24 hours then the patient may be discharged to take the medicine at home
After discharge patients will be seen and examined in clinic daily for the first 5 days then on day 7 and after that every other day until the shingles show evidence of healing A final physical exam and blood tests occur on day 21
A small amount of fluid will be taken from one of the shingles lesions using a very fine needle to verify the presence of the virus that causes shingles This will be done before the first dose of Valacyclovir and 3 days later
Blood tests no more than 2 teaspoons will be performed twice a week to monitor for toxic effects of the drug Blood samples will be drawn to evaluate the pharmacology of this drughow the body handles the drug Nine blood samples less than one teaspoon each will be obtained over 24 hours during the first day of treatment The total amount of blood to be drawn is 9 teaspoons 3 tablespoons
For children that are toilet trained urine will be collected for 12 hours at the start of the study This urine will be used to evaluate kidney function and the pharmacology of valacyclovir If there are unacceptable side effects or if there is evidence that the disease is spreading despite being on Valacyclovir for more than 48 hours then you will be taken off the study and started on acyclovir by vein
Patients Undergoing Bone Marrow Transplantation
Patients undergoing a bone marrow transplant will receive a single dose of valacyclovir in place of their first scheduled dose of acyclovir They will then receive acyclovir as outlined by their physician
Blood samples will be drawn to evaluate the pharmacology how the body handles the drug of the study drug Fifteen blood samples less than one teaspoon each will be obtained over 24 hours during the first day of treatment The total amount of blood to be drawn is 9 teaspoons 3 tablespoons The total amount of blood drawn for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5 of the patients total blood volume This amount of blood loss is a safe amount even for small children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None