Clinical Trial: Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary:
OBJECTIVES:
I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.
Detailed Summary:
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks.
Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).
Sponsor: National Center for Research Resources (NCRR)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Office of Rare Diseases (ORD)
Dates:
Date Received: October 18, 1999
Date Started: December 1991
Date Completion:
Last Updated: June 23, 2005
Last Verified: July 2000