NCT02351102

Brief Summary

The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

January 18, 2015

Last Update Submit

July 14, 2019

Conditions

Congenital Cytomegalovirus Infection

Keywords

Congenital CMVCongenital Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

  • CMV Polymerase Chain Reaction (PCR) in amniotic fluid

    amniocentesis will be performed no earlier than 21 weeks gestation, and at least 7 weeks after estimated seroconversion occured. Therefore, the time frame for amniocentesis is estimated between 21 weeks gestation to 28 weeks gestation

    minimum 21 weeks gestation

Secondary Outcomes (1)

  • Clinical evidence of symptomatic congenital CMV infection

    within 1 week after delivery

Study Arms (2)

Valacyclovir

ACTIVE COMPARATOR

Participants will receive Valacyclovir at a dose of 8g/d starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation)

Drug: Valacyclovir

Placebo

PLACEBO COMPARATOR

Participants will receive placebo pills (same daily amount as the intervention group) starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation)

Drug: Placebo

Interventions

ValacyclovirDRUG
Valacyclovir
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally

You may not qualify if:

  • Patients with preexisting liver disease, renal dysfunction, bone marrow suppression or sensitivity to Acyclovir will be excluded from the study - as will patients receiving any antiviral therapy prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Schneider Hospital for Women

Petah Tikva, Israel

Location

Related Publications (6)

  • Buonsenso D, Serranti D, Gargiullo L, Ceccarelli M, Ranno O, Valentini P. Congenital cytomegalovirus infection: current strategies and future perspectives. Eur Rev Med Pharmacol Sci. 2012 Jul;16(7):919-35.

    PMID: 22953641BACKGROUND

  • Gaytant MA, Steegers EA, Semmekrot BA, Merkus HM, Galama JM. Congenital cytomegalovirus infection: review of the epidemiology and outcome. Obstet Gynecol Surv. 2002 Apr;57(4):245-56. doi: 10.1097/00006254-200204000-00024.

    PMID: 11961482BACKGROUND

  • Ornoy A, Diav-Citrin O. Fetal effects of primary and secondary cytomegalovirus infection in pregnancy. Reprod Toxicol. 2006 May;21(4):399-409. doi: 10.1016/j.reprotox.2005.02.002.

    PMID: 16580941BACKGROUND

  • Bodeus M, Kabamba-Mukadi B, Zech F, Hubinont C, Bernard P, Goubau P. Human cytomegalovirus in utero transmission: follow-up of 524 maternal seroconversions. J Clin Virol. 2010 Feb;47(2):201-2. doi: 10.1016/j.jcv.2009.11.009. Epub 2009 Dec 16. No abstract available.

    PMID: 20006542BACKGROUND

  • Jacquemard F, Yamamoto M, Costa JM, Romand S, Jaqz-Aigrain E, Dejean A, Daffos F, Ville Y. Maternal administration of valaciclovir in symptomatic intrauterine cytomegalovirus infection. BJOG. 2007 Sep;114(9):1113-21. doi: 10.1111/j.1471-0528.2007.01308.x. Epub 2007 Jul 6.

    PMID: 17617198RESULT

  • Shahar-Nissan K, Pardo J, Peled O, Krause I, Bilavsky E, Wiznitzer A, Hadar E, Amir J. Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 12;396(10253):779-785. doi: 10.1016/S0140-6736(20)31868-7.

    PMID: 32919517DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Keren Shahar-Nissan, Dr

    Schneider Children's Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paediatrics C ward, Schneider Children's Medical Centre of Israel

Study Record Dates

First Submitted

January 18, 2015

First Posted

January 30, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

IL(1)