In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir (CYMEVAL)

This study has been terminated.
(not enough inclusion)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01037712
First received: December 21, 2009
Last updated: October 12, 2012
Last verified: February 2011
  Purpose

The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal 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 against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.


Condition Intervention Phase
Viral Disease
Cytomegalovirus Infection
Drug: Valacyclovir (ZELITREX)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir: Prospective Multicenter Randomized Trial Versus Placebo

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 fetal infection with CMV) at 24 hours [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: six months ] [ Designated as safety issue: Yes ]
  • the compliance at one month [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • the criteria of tolerance [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZELITREX
ZELITREX
Drug: Valacyclovir (ZELITREX)
2g, 8g/day, 4 a day 23 weeks maximum.
Other Name: Valacyclovir (ZELITREX)
Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo
Other Name: placebo

Detailed Description:

The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal 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 against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.

To evaluate the effect of a treatment by valacyclovir injected per bone to the mother in the cases of proven fetal 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 in the treated group, 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 fetal anomalies.

The secondary objective is a reduction in the treated group, of the CMV viral load in the blood of the cord taken at birth.

The attribution of the treatments will be carried out by drawing lot, according to a procedure in double blind as of the established diagnosis of the fetal infection. In the absence of reference treatment, a placebo will be employed in the reference group. The patients included will be thus placed in one of the 2 parallel groups. 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 82 in each group. 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 fetal 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,
  • Fetal 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,
  • 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:

  • No 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,
  • Patients whose fetus does not present any echographic sign being able to be in connection with the infection with CMV,
  • Patients whose fetus presents at least one cerebral echographic anomaly:IntraparenchymalVentriculomegaly measured with the ventricular crossroads ≥ 12mm

    • Hyperechogenicity periventricular
    • Hydrocephaly
    • Intra-ventricular adherence
    • Microcephaly
    • Increase cuts large retro-cerebellar cistern
    • Hypoplasia vermis
    • Intraparenchymal calcifications
    • Porencephaly
    • Lissencephaly
    • Cysts periventricular
    • Hypoplasia of the callous body
    • Signs of LENTICULO-striated vasculopathy
  • 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: NCT01037712

Locations
France
Hospital Necker Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves VILLE, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01037712     History of Changes
Other Study ID Numbers: P070115
Study First Received: December 21, 2009
Last Updated: October 12, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Foetuses infection with CMV
neurological handicap of infectious origin.

Additional relevant MeSH terms:
Cytomegalovirus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014