NCT00004278

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1991

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2000

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus Infections

Keywords

congenital cytomegalovirus infectioncytomegalovirus infectionherpesvirus infectionimmunologic disorders and infectious disordersneonatal disordersrare diseaseviral infection

Interventions

ganciclovirDRUG

Eligibility Criteria

Age0 Years - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Symptomatic cytomegalovirus (CMV) infection: Central nervous system disease, with or without other organ system involvement, e.g.: Microcephaly, i.e., less than 5% for age Radiologic changes indicating brain disease Cerebrospinal fluid exam abnormal for age Chorioretinitis Hearing defects * CMV confirmed by urine, throat, buffy coat, and/or conjunctiva culture * No hydroencephalopathy or other devastating brain involvement --Prior/Concurrent Therapy-- * No concurrent antiviral agent No concurrent immune globulin --Patient Characteristics-- * Age: Under 1 month (preferably under 2 weeks) * Life expectancy: No imminent demise * Renal: Creatinine no greater than 1.5 mg/dL * Other: Birth weight at least 1200 g Gestational age at least 32 weeks No HIV infection No concurrent bacterial infection Eligible if resolved following 2-week treatment and CMV symptoms persist

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cytomegalovirus InfectionsHerpesviridae InfectionsImmune System DiseasesCommunicable DiseasesInfant, Newborn, DiseasesRare DiseasesVirus Diseases

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

DNA Virus InfectionsInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Richard J. Whitley

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

December 1, 1991

Last Updated

June 24, 2005

Record last verified: 2000-07