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NCT01659684 Clinical Trial

Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection

Cytomegalovirus Congenital Infection Clinical Trial

Official title:
Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01659684
Other study ID # IVIG-001
Secondary ID
Status Recruiting
Phase N/A
First received August 1, 2012
Last updated August 3, 2012
Start date October 2010
Est. completion date November 2014

Study information
Verified date August 2012
Source Fondazione Onlus Camillo De Lellis
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• standard intravenous immunoglobulin
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection

Locations
Country Name City State
Italy Infection Disease Unit, Pescara General Hospital, Pescara, Italy Pescara Abruzzo

Sponsors (3)
Lead Sponsor Collaborator
Fondazione Onlus Camillo De Lellis Azienda Sanitaria Locale di Pescara, Regione Abruzzo, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of neurological damage due to Cytomegalovirus congenital infection Number of infected newborns with neurological deficits divided by the total number of infected newborns Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue No
Secondary Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection Number of women with symptoms or adverse events during infusions divided by the total number of treated women 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 Yes

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