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Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Primary Purpose

Congenital Cytomegalovirus Infection

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Valacyclovir

Placebo

About this trial

This is an interventional prevention trial for Congenital Cytomegalovirus Infection focused on measuring Congenital CMV, Congenital Cytomegalovirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Helen Schneider Hospital for Women

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Valacyclovir

Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical evidence of symptomatic congenital CMV infection

laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth

Full Information

NCT ID

NCT02351102

First Posted

January 18, 2015

Last Updated

July 14, 2019

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02351102

Brief Title

Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Official Title

Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

A randomized, double-blind, placebo-controlled study. Participants: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester Intervention: After informed consent and randomization, participants in the treatment group will receive Valacyclovir at a dose of 8 g/d. Participants in the control group will receive the same amount of daily pills containing placebo. Treatment will continue until amniocentesis, which will determine if the fetus was infected.

6. Conditions and Keywords

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

Congenital Cytomegalovirus Infection

Keywords

Congenital CMV, Congenital Cytomegalovirus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valacyclovir

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Valacyclovir

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

CMV Polymerase Chain Reaction (PCR) in amniotic fluid

Description

Time Frame

minimum 21 weeks gestation

Secondary Outcome Measure Information:

Title

Clinical evidence of symptomatic congenital CMV infection

Description

laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth

Time Frame

within 1 week after delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keren Shahar-Nissan, Dr

Organizational Affiliation

Schneider Children's Medical Center, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helen Schneider Hospital for Women

City

Petah Tikva

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

22953641

Citation

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.

Results Reference

background

PubMed Identifier

11961482

Citation

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.

Results Reference

background

PubMed Identifier

16580941

Citation

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.

Results Reference

background

PubMed Identifier

20006542

Citation

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.

Results Reference

background

PubMed Identifier

17617198

Citation

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.

Results Reference

result

PubMed Identifier

32919517

Citation

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. Erratum In: Lancet. 2020 Oct 10;396(10257):1070.

Results Reference

derived

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Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

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