Treat-CMV

Phase 1

Recruiting

Conditions: congenital CMV infection
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: CTIS2022-500714-25-01

Lead Sponsor: Z Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 112

Inclusion Criteria

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures, 18 years or older, Proven first trimester primary CMV infection

Exclusion Criteria

Participant has a history of kidney function problems, liver function problems, immunocomprimised, Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol, Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial, Participation in an interventional Trial with an investigational medicinal product (IMP) or device

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aims to investigate the effectivity of valaciclovir to prevent vertical CMV transmission during pregnancy in first trimester primary maternal CMV infections.;Secondary Objective: long-term safety of valaciclovir treatment during pregnancy in the mother and in the patient, Increase patient awareness of CMV during pregnancy, Standardize first trimester CMV screening for pregnant women, Recalculate the cost-effectiveness of population screening for CMV during pregnancy in Flanders;Primary end point(s): The rate of vertical transmission, assessed by CMV PCR on amniotic fluid collected during an amniocentesis at 20w. This result will be reconfirmed by PCR on a urine sample postnatally.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Imaging abnormalities indicative for vertical transmission assed on ultrasound two weekly and on MRI at 30w GA.;Secondary end point(s):Maternal safety assessed by blood analysis (hematology, liver function, kidney function) and clinically;Secondary end point(s):Fetal safety assessed by ultrasound prenatally, blood analysis at birth on umbilical cord blood (hematology, liver function), postnatal urine sample, MRI postnatally;Secondary end point(s):Long term effects: hearing assessment yearly until year 4 and neurodevelopmental follow-up at 1,2 and 5 years of age.