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Clinical trial (study) comparing the efficacy and safety of valacyclovir used in the prevention and treatment of primary cytomegalovirus (CMV) infection in pregnant women depending on the used drug dose.
EU CTIS ID: 2023-508643-46-00
What this study is testing
The aim of the study is to compare the efficacy and safety of valacyclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary CMV infection in a dose-dependent manner.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pregnant women aged 18 years and older.
- The presence of IgG antibodies to CMV, whose previous result in the current pregnancy was negative (seroconversion) and/or antibodies to CMV in the IgM and IgG classes with low avidity (below 50% or index marked by the laboratory as low avidity)
- The presence of the above-mentioned antibodies before 16 weeks of pregnancy.
- Giving written informed consent to participate in the study.
- Confirmed singleton or twin pregnancy.
You likely can't join if
- Pregnant women aged under 18.
- Known allergy or hypersensitivity to valacyclovir or acyclovir.
- Mental disorder or intellectual disability.
- Renal disease, abnormal liver function parameters, chronic diseases.
- A patient who participated in any other clinical trial 3 months before enrollment in the study.
- Positive result of screening tests for viral diseases performed routinely in accordance with the standard of perinatal care (HBV, HIV, HCV), active/recent TOXO infection, WR.
See the full eligibility criteria
- Pregnant women aged 18 years and older.
- The presence of IgG antibodies to CMV, whose previous result in the current pregnancy was negative (seroconversion) and/or antibodies to CMV in the IgM and IgG classes with low avidity (below 50% or index marked by the laboratory as low avidity)
- The presence of the above-mentioned antibodies before 16 weeks of pregnancy.
- Giving written informed consent to participate in the study.
- Confirmed singleton or twin pregnancy.
- Pregnant women aged under 18.
- Known allergy or hypersensitivity to valacyclovir or acyclovir.
- Mental disorder or intellectual disability.
- Renal disease, abnormal liver function parameters, chronic diseases.
- A patient who participated in any other clinical trial 3 months before enrollment in the study.
- Positive result of screening tests for viral diseases performed routinely in accordance with the standard of perinatal care (HBV, HIV, HCV), active/recent TOXO infection, WR.
- Patients not vaccinated against tuberculosis.
- Contraindications to magnetic resonance imaging.
- Multiple pregnancy (more than twins).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.