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

NCT ID: NCT01659684

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Cytomegalovirus Congenital Infection

Keywords

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congenital CMV infection standard immunoglobulins immunoglobulin therapy IgG CMV avidity index Cytomegalovirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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standard intravenous immunoglobulin

Single arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls.

Group Type EXPERIMENTAL

standard intravenous immunoglobulin

Intervention Type BIOLOGICAL

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

Interventions

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standard intravenous immunoglobulin

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regione Abruzzo, Italy

UNKNOWN

Sponsor Role collaborator

Azienda Sanitaria Locale di Pescara

OTHER

Sponsor Role collaborator

Fondazione Onlus Camillo De Lellis

OTHER

Sponsor Role lead

Responsible Party

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Dr. Giustino Parruti

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giustino Parruti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Sanitaria Locale di Pescara

Locations

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Infection Disease Unit, Pescara General Hospital, Pescara, Italy

Pescara, Abruzzo, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Francesca D'Arcangelo, MD

Role: primary

Antonina Sciacca, Secretary

Role: backup

Related Links

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http://www.fondazionedelellis.org

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

Other Identifiers

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IVIG-001

Identifier Type: -

Identifier Source: org_study_id