Trials / Completed

CompletedNCT00004278

Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 130 (planned)

Sponsor: National Center for Research Resources (NCRR) · NIH
Sex: All
Age: 0 Years – 1 Month
Healthy volunteers: Not accepted

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 description

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).

Conditions

Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	ganciclovir

Timeline

Start date: 1991-12-01
First posted: 1999-10-19
Last updated: 2005-06-24

Source: ClinicalTrials.gov record NCT00004278. Inclusion in this directory is not an endorsement.