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

This study has been completed.

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004278

Purpose

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	Intervention	Phase
Cytomegalovirus Infections	Drug: ganciclovir	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Ganciclovir Ganciclovir sodium

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	130
Study Start Date:	December 1991

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).

Eligibility

Ages Eligible for Study:	up to 1 Month
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004278

Sponsors and Collaborators

National Center for Research Resources (NCRR)

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Richard J. Whitley

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004278 History of Changes
Other Study ID Numbers:	199/11689, NIAID-558607
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

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:

Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir

Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012