Clinical Trial: Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prevention of Human Cytomegalovirus (HCMV) Mother-to-fetus Transmission by Administration of Virus-specific Hyperimmune Globulin to Pregnant Women With Primary HCMV Infection

Brief Summary: The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.

Detailed Summary:

HCMV is the leading infectious cause of mental retardation and deafness in infants with congenital HCMV infection. Primary HCMV infections during pregnancy carry the highest risk of fetal infection and disease. No intervention of proven efficacy is available in case of primary HCMV infection in pregnancy. However, a study published in 2005 (Nigro et al., NEJM 353:1350-62, 2005) reported that in pregnant women with primary HCMV infection treated with HCMV-specific hyperimmune globulin (Cytotect®, Biotest) the risk of transmitting the infection to the fetus was reduced from 40% to 16%. Unfortunately, since the study was conducted with inadequate controls, the actual efficacy of hyperimmune globulin could not be properly assessed.

In the present randomized, double-blind, placebo-controlled, multicenter trial pregnant women with ascertained primary HCMV infection at 4-26 weeks of gestation will be randomized to receive Cytotect® or placebo intravenously within 6 weeks after the presumed onset of infection.

Primary efficacy parameter will be the number of HCMV-infected newborns or fetuses.


Sponsor: IRCCS Policlinico S. Matteo

Current Primary Outcome: Evidence of congenital HCMV infection in the fetus/newborn [ Time Frame: At amniocentesis and/or within one week after birth ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • HCMV-specific immune response (humoral and cell-mediated) [ Time Frame: 36-48 months ]
  • Virological and histological findings in placentas [ Time Frame: 36-48 months ]
  • Clinical outcome of newborns with congenital HCMV infection [ Time Frame: within 2 weeks after birth ]
  • Safety of Cytotect in the mother and newborn [ Time Frame: within 24 hours after delivery ]


Original Secondary Outcome: Same as current

Information By: IRCCS Policlinico S. Matteo

Dates:
Date Received: April 14, 2009
Date Started: June 2009
Date Completion:
Last Updated: December 7, 2011
Last Verified: December 2011