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

Congenital Cytomegalovirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351102
• Other study ID #: 655-14
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2015
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Congenital Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infection

Intervention

Drug:
• Valacyclovir

• Placebo

Locations

Country	Name	City	State
Israel	Helen Schneider Hospital for Women	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Bodéus 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. — View 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. Review. — View 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. Review. — View 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. Epub 2007 Jul 6. — View Citation

Ornoy A, Diav-Citrin O. Fetal effects of primary and secondary cytomegalovirus infection in pregnancy. Reprod Toxicol. 2006 May;21(4):399-409. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical evidence of symptomatic congenital CMV infection	laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth	within 1 week after delivery