Clinical trial NCT01659684: Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
Official title: Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cytomegalovirus Congenital Infection
Keywords: congenital CMV infection
standard immunoglobulins
immunoglobulin therapy
IgG CMV avidity index
Cytomegalovirus
Lead sponsor: Fondazione Onlus Camillo De Lellis
Sponsor class: OTHER
Collaborators: name: Regione Abruzzo, Italy
name: Azienda Sanitaria Locale di Pescara
First posted: 2012-08-08
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Because the potential benefit of standard intravenous immunoglobulins (IVIG) - obtained from unselected donor pools including a varying proportion of donors previously exposed to CMV - has not yet been explored in pregnant women, the investigators performed a longitudinal prospective study on the possible efficacy of IVIG for prevention or therapy of fetal CMV infection.

Detailed description: Human IVIG are offered monthly to consecutive enrolled pregnant women with confirmed primary CMV infection at any stage, for the prevention and treatment of fetal CMV infection. Primary infection is defined by positive CMV IgM antibodies with absent or low titres of CMV IgG antibodies, and either low (\<40%) CMV IgG avidity indexes with positive CMV IgM AND IgG antibodies. In addition women with indefinite avidity index and positive CMV DNA detection in urine and/or blood samples are also considered for treatment. Standard human intravenous immunoglobulins were chosen for their safety and efficacy, well documented in other settings. IVIGs were used to perform all of the infusions in the study, undiluted after reconstitution, in accordance with instructions of the manufacturer. We chose to perform IVIG infusions using 0.5 g/Kg of body weight, to make sure that a dose of specific CMV IgG at least comparable with that carried by HIG were infused at each time point. Infusions last 4 to 5 hours, using a double lumen line to infuse approximately 1500 mL of either 5% glucose or saline solution in parallel with the undiluted IVIG preparation, to reduce the risk of infusion reactions.

CMV IgG and IgM antibodies and IgG avidity indexes are assayed before and after each IVIG infusion, within 15 minutes. Quantitative CMV DNA is amplified from whole blood and urine samples from pregnant women and neonates, using the Real-Time PCR, and on samples of amniotic fluid from women who required amniocentesis. The newborns will be followed for five years after delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with confirmed primary CMV infection at any stage of gestation.

Exclusion Criteria:

* Pregnant women with falsely positive CMV IgM antibodies or high (\>40%) CMV IgG avidity indexes

Primary outcomes:
measure: Prevention of neurological damage due to Cytomegalovirus congenital infection
timeFrame: Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue
Secondary outcomes:
measure: Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection
timeFrame: Participants are followed during the infusion period, an expected average of 5 hours; possible minor side-effects are searched for at each follow up visit
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Infection Disease Unit, Pescara General Hospital, Pescara, Italy
state: Abruzzo
Study officials:
affiliation: Azienda Sanitaria Locale di Pescara
name: Giustino Parruti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: