Back to results

In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir (CYMEVAL2)

Primary Purpose

Foetuses Infection, Cytomegalovirus (CMV)Infection

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Valacyclovir arrow

About this trial

This is an interventional treatment trial for Foetuses Infection focused on measuring viral disease, cytomegalovirus infection, is the first cause, of congenital, neurological handicap, of infectious origin.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria :

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
- 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.

Exclusion criteria :

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

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.

Sites / Locations

Hospital Necker Enfants Malades

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valacyclovir arrow

Arm Description

Experimental : Valacyclovir arrow 500mg give Valacyclovir arrow to all participants (open phase)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01651585

First Posted

July 25, 2012

Last Updated

July 20, 2015

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01651585

Brief Title

In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir

Acronym

CYMEVAL2

Official Title

In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foetuses Infection, Cytomegalovirus (CMV)Infection

Keywords

viral disease, cytomegalovirus infection, is the first cause, of congenital, neurological handicap, of infectious origin.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valacyclovir arrow

Arm Type

Experimental

Arm Description

Experimental : Valacyclovir arrow 500mg give Valacyclovir arrow to all participants (open phase)

Intervention Type

Drug

Intervention Name(s)

Valacyclovir arrow

Intervention Description

dosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum

Primary Outcome Measure Information:

Title

pregnancies with unfavourable exit

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

the viral load

Description

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

Time Frame

1 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : 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 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. Exclusion criteria : 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

VILLE YVES, MD

Organizational Affiliation

Hospital Necker Enfants Malades, Paris France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Necker Enfants Malades

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

36298700

Citation

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.

Results Reference

derived

PubMed Identifier

30596974

Citation

Faure-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.

Results Reference

derived

Learn more about this trial

In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir

We'll reach out to this number within 24 hrs