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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ganciclovir

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring congenital cytomegalovirus infection, cytomegalovirus infection, herpesvirus infection, immunologic disorders and infectious disorders, neonatal disorders, rare disease, viral infection

Eligibility Criteria

0 Years - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004278

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00004278

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2000

Overall Recruitment Status

Completed

Study Start Date

December 1991 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Allocation

Randomized

Enrollment

130 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ganciclovir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

1 Month

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard J. Whitley

Official's Role

Study Chair

Cytomegalovirus Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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