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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
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Office of Rare Diseases (ORD)

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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Drug: ganciclovir Phase 3

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).


Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : December 1991






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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Richard J. Whitley

ClinicalTrials.gov Identifier: NCT00004278     History of Changes
Other Study ID Numbers: 199/11689
NIAID-558607
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2000

Keywords provided by Office of Rare Diseases (ORD):
congenital cytomegalovirus infection
cytomegalovirus infection
herpesvirus infection
immunologic disorders and infectious disorders
neonatal disorders
rare disease
viral infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action