Neurodevelopmental outcomes following ganciclovir therapy in symptomatic congenital cytomegalovirus infections involving the central nervous system.
Sara E Oliver, Gretchen A Cloud, Pablo J Sánchez...
https://pubmed.ncbi.nlm.nih.gov/19766534Completed
Phase 3
Age: 0 - 1Month
All Genders
ID00001100
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2010-08-27
130
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the benefits and safety of the antiviral drug ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body, resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain damage in a large percentage of surviving babies. Children in this study have a CMV infection of the central nervous system (CNS).
CONDITIONS
Official Title
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
Who Can Participate
Age: 0 - 1Month
All Genders
Eligibility Criteria
You may qualify if you...
Infants may be eligible for this study if they:
- Were full term infants (at least 32 weeks gestation).
- Are 1 month of age or younger (preferably less than 2 weeks).
- Weighed at least 1,200 grams (2.5 lbs) at birth.
- Have confirmed cytomegalovirus.
- Have evidence of CMV infection of the CNS with or without evidence of other organ involvement.
You will not qualify if you...
Infants will not be eligible for this study if they:
- Have concurrent bacterial infection.
- Have HIV infection.
- Have mild symptoms or no symptoms of CMV infection at birth.
- Have an abnormal brain development (hydranencephaly) or any devastating brain involvement.
Trial Site Locations
Total: 1 location
1
NIAID/DMID/CASG Central Unit
Birmingham, Alabama, United States, 35294
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here