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OpenTrials
Completed

NCT Number: NCT00004278

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

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.

Completed

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Key information

Conditions

Cytomegalovirus Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Disease Attributes Herpesviridae Infections Immune System Diseases Infant, Newborn, Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Virus Diseases

Age range

0 year–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganciclovir

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
1991
First posted
Oct 19, 1999
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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