Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
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|ClinicalTrials.gov Identifier: NCT00004278|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections||Drug: ganciclovir||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||130 participants|
|Study Start Date :||December 1991|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004278
|Study Chair:||Richard J. Whitley|