Trial record 1 of 2 for:    Neurological Consequences of Cytomegalovirus Infection
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Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection

This study is currently recruiting participants.
Verified August 2012 by Fondazione Onlus Camillo De Lellis
Sponsor:
Collaborators:
Regione Abruzzo, Italy
Azienda Sanitaria Locale di Pescara
Information provided by (Responsible Party):
Dr. Giustino Parruti, Azienda Sanitaria Locale di Pescara
ClinicalTrials.gov Identifier:
NCT01659684
First received: August 1, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Cytomegalovirus Congenital Infection
Biological: standard intravenous immunoglobulin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection

Resource links provided by NLM:


Further study details as provided by Fondazione Onlus Camillo De Lellis:

Primary Outcome Measures:
  • Prevention of neurological damage due to Cytomegalovirus congenital infection [ Time Frame: Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue ] [ Designated as safety issue: No ]
    Number of infected newborns with neurological deficits divided by the total number of infected newborns


Secondary Outcome Measures:
  • Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    Number of women with symptoms or adverse events during infusions divided by the total number of treated women


Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: standard intravenous immunoglobulin
Single arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls.
Biological: standard intravenous immunoglobulin
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational 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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659684

Locations
Italy
Infection Disease Unit, Pescara General Hospital, Pescara, Italy Recruiting
Pescara, Abruzzo, Italy, 65124
Contact: Francesca D'Arcangelo, MD       francescadarcangelo@yahoo.it   
Contact: Antonina Sciacca, Secretary       a.sciacca@virgilio.it   
Sponsors and Collaborators
Fondazione Onlus Camillo De Lellis
Regione Abruzzo, Italy
Azienda Sanitaria Locale di Pescara
Investigators
Principal Investigator: Giustino Parruti, MD, PhD Azienda Sanitaria Locale di Pescara
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Giustino Parruti, MD, PhD, Azienda Sanitaria Locale di Pescara
ClinicalTrials.gov Identifier: NCT01659684     History of Changes
Other Study ID Numbers: IVIG-001
Study First Received: August 1, 2012
Last Updated: August 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Onlus Camillo De Lellis:
congenital CMV infection
standard immunoglobulins
immunoglobulin therapy
IgG CMV avidity index
Cytomegalovirus

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014