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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01651585
First received: July 25, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Foetuses Infection
Cytomegalovirus (CMV)Infection
Drug: Valacyclovir arrow
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • pregnancies with unfavourable exit [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 43
Study Start Date: July 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valacyclovir arrow
Experimental : Valacyclovir arrow 500mg give Valacyclovir arrow to all participants (open phase)
Drug: Valacyclovir arrow
dosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651585

Locations
France
Hospital Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: Yves Ville, MD    33 (0)1 44 49 40 30    Yville@gmail.com   
Contact: Laurent Julien Salomon, MD    33 (0)1 44 49 40 30    laurentsalomon@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: VILLE YVES, MD Hospital Necker Enfants Malades, Paris France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01651585     History of Changes
Other Study ID Numbers: P070708
Study First Received: July 25, 2012
Last Updated: June 13, 2014
Health Authority: French: ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
viral disease
cytomegalovirus infection
is the first cause
of congenital
neurological handicap
of infectious origin.

Additional relevant MeSH terms:
Communicable Diseases
Infection
Acyclovir
Valacyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014