Foetuses InfectionPhase 4CYMEVAL2NCT01651585
In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir
A Phase 4 study testing Valacyclovir arrow in people with Foetuses Infection and Cytomegalovirus (CMV)Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Foetuses Infection, Cytomegalovirus (CMV)Infection
- What is being tested?
- Valacyclovir arrow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Fœtal Infection with CMV authenticated by the positivity of the research of the viral genome by PCR in the amniotic liquid,
- Echographic Assessment revealing at least one cerebral extra anomaly being able to be in connection with the infection with CMV,
- And/or one isolated cerebral anomaly :
- Ventriculomégalie measured with the ventricular crossroads < 15mm
- Signs of lenticulo-striated vasculopathy
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- Intraparenchymateuses calcifications
- Intra-ventricular adherences
- And/or biological signs of generilazed infection to CMV :
- fetal viremia > 3000 copies/ml
- platelet < 100 000/cc
- Absence of request for termination of pregnancy from the start,
- Acceptance of a strict follow-up by a Multi-field Center of Prenatal diagnosis and of an optimal observance of the founded treatment,
- Collection of the written assent to take part in the test.
- Affiliation with a mode of social security or equivalent.
Who cannot join
- Not affiliation with a mode of social security (profit or having right)
- Patient of less than 18 years,
- Patient presenting another pathology obstetrical or medical (in particular hepatic or renal) preexistent to tracking or contra-indicating the use of valacyclovir,
- Patientes whose fœtus does not present any echographic sign being able to be in connection with the infection with CMV,
- Patientes whose fœtus presents at least one cerebral echographic anomaly :
- Ventriculomégalie measured with the ventricular crossroads ≥ 15mm Hyperechogenicity periventriculaire Hydrocephaly Microcephaly Increase cuts large retro-cérébelleuse cistern Hypoplasy vermienne Porencephaly Lissencephaly Cysts périventriculaires Hypoplasy of the callous body
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- Patient under any other active antiviral treatment against CMV,
- Patient taking part in another therapeutic test,
- Patient refusing to sign the enlightened assent,
- Patient formulating a request for medical interruption of pregnancy before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study. Decrease the fœtal viral load could make possible to decrease symptomatology néonatale in a group of infected fœtuses.
Read the detailed description
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study. Decrease the fœtal viral load could make possible to decrease symptomatology néonatale in infected fœtuses.
To evaluate the effect of a treatment by valacyclovir injected per bone to the mother in the cases of proven fœtal infection with CMV (positive PCR CMV in the amniotic liquid) and presenting cerebral extra echographic signs being able to be allotted to the infection.
The main objective is to observe a reduction in the number of unfavourable exits (symptomatic children at birth) and a reduction in the number of medical interruptions of pregnancy practised for fœtal anomalies.
The secondary objective is a reduction of the CMV viral load in the blood of the cord taken at birth.
The patients included will be treated. The observance will be evaluated. Taking into consideration our preliminary study, a difference of 20% between the 2 groups can be discounted. The number calculated of subjects to include in the test in order to guarantee a power of 80% to him is of 43. Recruitment will be carried out in a multicentric way. The necessary duration of inclusion will be 36 months
The comparison of the two treatments will be carried out on the composite principal criterion according to : proportion of pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fœtal infection with CMV).
The secondary criteria of judgement will be : the viral load in the blood of the cord of the newborns infected in utero by CMV, the compliance and the criteria of tolerance.
- Conditions
- Foetuses Infection, Cytomegalovirus (CMV)Infection
- Being tested
- Valacyclovir arrow
- Keywords
- viral disease, cytomegalovirus infection, is the first cause, of congenital, neurological handicap, of infectious origin.
- Medical subject headings
- Cytomegalovirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir arrowDrug
dosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir arrow | Experimental | Experimental : Valacyclovir arrow 500mg give Valacyclovir arrow to all participants (open phase) Receives: Drug: Valacyclovir arrow |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancies with unfavourable exit
pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fœtal infection with CMV) at 24 hours
Measured: 24 hours
Secondary outcomes (1)
the viral load
the viral load in the blood of the cord of the newborns infected in utero by CMV the compliance at one month the criteria of tolerance
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Foetuses InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- VILLE YVES, MD, Principal investigator, Hospital Necker Enfants Malades, Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651585
- Sponsor's protocol ID
- P070708
- Acronym
- CYMEVAL2
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2012
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bourgon N, Fitzgerald W, Aschard H, Magny JF, Guilleminot T, Stirnemann J, Romero R, Ville Y, Margolis L, Leruez-Ville M. Cytokine Profiling of Amniotic Fluid from Congenital Cytomegalovirus Infection. Viruses. 2022 Sep 28;14(10):2145. doi: 10.3390/v14102145.
PubMed 36298700Leruez-Ville M, Ghout I, Bussieres L, Stirnemann J, Magny JF, Couderc S, Salomon LJ, Guilleminot T, Aegerter P, Benoist G, Winer N, Picone O, Jacquemard F, Ville Y. In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study. Am J Obstet Gynecol. 2016 Oct;215(4):462.e1-462.e10. doi: 10.1016/j.ajog.2016.04.003. Epub 2016 Apr 13.
PubMed 27083761Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussieres L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.
PubMed 30596974
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial
- ClinicalTrials.gov ID
- NCT01651585
- Acronym / sponsor ID
- CYMEVAL2 / P070708
- Conditions
- Foetuses Infection, Cytomegalovirus (CMV)Infection
- Keywords
- viral disease, cytomegalovirus infection, is the first cause, of congenital, neurological handicap, of infectious origin.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jul 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study. Decrease the fœtal viral load could make possible to decrease symptomatology néonatale in a group of infected fœtuses.
Detailed description
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study. Decrease the fœtal viral load could make possible to decrease symptomatology néonatale in infected fœtuses.
To evaluate the effect of a treatment by valacyclovir injected per bone to the mother in the cases of proven fœtal infection with CMV (positive PCR CMV in the amniotic liquid) and presenting cerebral extra echographic signs being able to be allotted to the infection.
The main objective is to observe a reduction in the number of unfavourable exits (symptomatic children at birth) and a reduction in the number of medical interruptions of pregnancy practised for fœtal anomalies.
The secondary objective is a reduction of the CMV viral load in the blood of the cord taken at birth.
The patients included will be treated. The observance will be evaluated. Taking into consideration our preliminary study, a difference of 20% between the 2 groups can be discounted. The number calculated of subjects to include in the test in order to guarantee a power of 80% to him is of 43. Recruitment will be carried out in a multicentric way. The necessary duration of inclusion will be 36 months
The comparison of the two treatments will be carried out on the composite principal criterion according to : proportion of pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fœtal infection with CMV).
The secondary criteria of judgement will be : the viral load in the blood of the cord of the newborns infected in utero by CMV, the compliance and the criteria of tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir arrow | Experimental | Drug: Valacyclovir arrowExperimental : Valacyclovir arrow 500mg give Valacyclovir arrow to all participants (open phase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years,
- Fœtal Infection with CMV authenticated by the positivity of the research of the viral genome by PCR in the amniotic liquid,
- Echographic Assessment revealing at least one cerebral extra anomaly being able to be in connection with the infection with CMV,
- And/or one isolated cerebral anomaly :
- And/or biological signs of generilazed infection to CMV :
Key exclusion criteria (10 listed)
- Not affiliation with a mode of social security (profit or having right)
- Patient of less than 18 years,
- Patient presenting another pathology obstetrical or medical (in particular hepatic or renal) preexistent to tracking or contra-indicating the use of valacyclovir,
- Patientes whose fœtus does not present any echographic sign being able to be in connection with the infection with CMV,
- Patientes whose fœtus presents at least one cerebral echographic anomaly :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valacyclovir arrowdosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum | Drug | Valacyclovir arrow |
Primary outcome
pregnancies with unfavourable exit
Time frame: 24 hours
pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fœtal infection with CMV) at 24 hours
1 secondary outcome
the viral load
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 36298700Bourgon N, Fitzgerald W, Aschard H, Magny JF, Guilleminot T, Stirnemann J, Romero R, Ville Y, Margolis L, Leruez-Ville M. Cytokine Profiling of Amniotic Fluid from Congenital Cytomegalovirus Infection. Viruses. 2022 Sep 28;14(10):2145. doi: 10.3390/v14102145.
- Results publication: PubMed 27083761Leruez-Ville M, Ghout I, Bussieres L, Stirnemann J, Magny JF, Couderc S, Salomon LJ, Guilleminot T, Aegerter P, Benoist G, Winer N, Picone O, Jacquemard F, Ville Y. In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study. Am J Obstet Gynecol. 2016 Oct;215(4):462.e1-462.e10. doi: 10.1016/j.ajog.2016.04.003. Epub 2016 Apr 13.
- Derived from this study: PubMed 30596974Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussieres L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VILLE YVES, MD principal investigator
Hospital Necker Enfants Malades, Paris France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valacyclovir arrow in people with Foetuses Infection and Cytomegalovirus (CMV)Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancies with unfavourable exit (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.