Cytomegalovirus Infection Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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