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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

December 1991

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Cytomegalovirus Infections

Intervention ^ICMJE

Drug: ganciclovir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 1 Month

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004278

Responsible Party

Study ID Numbers ^ICMJE

199/11689, NIAID-558607

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators ^ICMJE

Study Chair:

Richard J. Whitley

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

July 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP