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

Information source: Fondazione Onlus Camillo De Lellis
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Congenital Infection

Intervention: standard intravenous immunoglobulin (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Fondazione Onlus Camillo De Lellis

Official(s) and/or principal investigator(s):
Giustino Parruti, MD, PhD, Principal Investigator, Affiliation: Azienda Sanitaria Locale di Pescara

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.

Clinical Details

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

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

Primary outcome: Prevention of neurological damage due to Cytomegalovirus congenital infection

Secondary outcome: Evaluate safety of aspecific immunoglobulins in pregnant women with primary 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

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Infection Disease Unit, Pescara General Hospital, Pescara, Italy, Pescara, Abruzzo 65124, Italy; Recruiting
Francesca D'Arcangelo, MD, Email: francescadarcangelo@yahoo.it
Antonina Sciacca, Secretary, Email: a.sciacca@virgilio.it
Additional Information

Click here for more information about this study: a similar link (Citomegalovirus - Ricerca per crescere) is included in the home page of this site

Starting date: October 2010
Last updated: August 3, 2012

Page last updated: February 07, 2013

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