Could 4 months of antiviral drugs be enough for CMV-Infected newborns?
NCT ID NCT07450365
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a 4-month course of antiviral medication (ganciclovir or valganciclovir) against the standard 6-month course for babies born with moderate-to-severe congenital CMV infection. The goal is to see if the shorter treatment works just as well at preventing long-term brain, hearing, and vision problems. About 150 newborns will be enrolled and followed until age 2.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ganciclovir or valganciclovir (antiviral drugs)
- What this could lead to
- If successful, this could show that a shorter 4-month treatment is just as effective as the standard 6-month course, reducing medication burden for babies with congenital CMV.
- What could go wrong
- This is a relatively small trial (150 babies) and is not yet recruiting. The shorter course might prove less effective at preventing long-term disabilities like hearing loss or developmental delays.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 30 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Confirmed congenital CMV infection (CMV DNA detected in urine, blood, or serum within 21 days after birth). 2. Clinical disease classified as moderate or severe symptomatic cCMV infection (defined by involvement of multiple systems, including at least one neurologic finding, or two or more central nervous system findings such as microcephaly, imaging abnormalities, SNHL, chorioretinitis, or positive CMV DNA in CSF). 3. Age at enrollment ≤ 30 days. 4. Written informed consent obtained from the parent(s) or legal guardian(s). Exclusion Criteria: 1. Gestational age \< 32 weeks. 2. Birth weight \< 1.8 kg. 3. Absence of informed consent. 4. Confirmed genetic mutations associated with hearing loss (e.g., GJB2). 5. Coexisting major genetic or metabolic diseases known to affect neurodevelopment. 6. Occurrence of other intracranial infections during the neonatal period. 7. Any condition that, in the opinion of the investigator, would make the infant unsuitable for the study or preclude evaluation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.