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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004278

Enrollment

130

Registered

1999-10-19

Start date

1991-12-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infections

Keywords

congenital cytomegalovirus infection, cytomegalovirus infection, herpesvirus infection, immunologic disorders and infectious disorders, neonatal disorders, rare disease, viral infection

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 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).

Interventions

DRUGganciclovir

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

0 Years to 1 Months

Healthy volunteers

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026