Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004644
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
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:
OBJECTIVES I Evaluate whether high-dose acyclovir decreases acute and long-term morbidity and mortality in neonates with central nervous system or disseminated herpes simplex virus HSV infection
II Evaluate whether high-dose acyclovir is safe and tolerated in the newborn III Assess resistance to antiviral medication IV Amplify disease classification for the purpose of predicting prognosis V Assess any changes in viral excretion patterns VI Evaluate whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid CSF predict long-term neurologic outcome
VII Evaluate whether specific antigens and antibodies in the CSF appear late after treatment and are indicative of insidious reactivation of virus in the brain
II Evaluate whether high-dose acyclovir is safe and tolerated in the newborn III Assess resistance to antiviral medication IV Amplify disease classification for the purpose of predicting prognosis V Assess any changes in viral excretion patterns VI Evaluate whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid CSF predict long-term neurologic outcome
VII Evaluate whether specific antigens and antibodies in the CSF appear late after treatment and are indicative of insidious reactivation of virus in the brain
Detailed Description:
PROTOCOL OUTLINE
Neonates are treated with intravenous acyclovir for 21 days Patients are followed at day 28 and at 6 12 24 36 and 48 months
Neonates are treated with intravenous acyclovir for 21 days Patients are followed at day 28 and at 6 12 24 36 and 48 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAID-17116 | None | None | None |