Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
Primary Purpose
Cytomegalovirus Congenital Infection
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
standard intravenous immunoglobulin
Sponsored by
About this trial
This is an interventional prevention trial for Cytomegalovirus Congenital Infection focused on measuring congenital CMV infection, standard immunoglobulins, immunoglobulin therapy, IgG CMV avidity index, Cytomegalovirus
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
Sites / Locations
- Infection Disease Unit, Pescara General Hospital, Pescara, ItalyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
standard intravenous immunoglobulin
Arm Description
Single arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls.
Outcomes
Primary Outcome Measures
Prevention of neurological damage due to Cytomegalovirus congenital infection
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
Number of women with symptoms or adverse events during infusions divided by the total number of treated women
Full Information
NCT ID
NCT01659684
First Posted
August 1, 2012
Last Updated
August 3, 2012
Sponsor
Fondazione Onlus Camillo De Lellis
Collaborators
Regione Abruzzo, Italy, Azienda Sanitaria Locale di Pescara
1. Study Identification
Unique Protocol Identification Number
NCT01659684
Brief Title
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Onlus Camillo De Lellis
Collaborators
Regione Abruzzo, Italy, Azienda Sanitaria Locale di Pescara
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Congenital Infection
Keywords
congenital CMV infection, standard immunoglobulins, immunoglobulin therapy, IgG CMV avidity index, Cytomegalovirus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard intravenous immunoglobulin
Arm Type
Experimental
Arm Description
Single arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls.
Intervention Type
Biological
Intervention Name(s)
standard intravenous immunoglobulin
Intervention Description
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection
Primary Outcome Measure Information:
Title
Prevention of neurological damage due to Cytomegalovirus congenital infection
Description
Number of infected newborns with neurological deficits divided by the total number of infected newborns
Time Frame
Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue
Secondary Outcome Measure Information:
Title
Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection
Description
Number of women with symptoms or adverse events during infusions divided by the total number of treated women
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giustino Parruti, MD, PhD
Organizational Affiliation
Azienda Sanitaria Locale di Pescara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infection Disease Unit, Pescara General Hospital, Pescara, Italy
City
Pescara
State/Province
Abruzzo
ZIP/Postal Code
65124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca D'Arcangelo, MD
Email
francescadarcangelo@yahoo.it
First Name & Middle Initial & Last Name & Degree
Antonina Sciacca, Secretary
Email
a.sciacca@virgilio.it
12. IPD Sharing Statement
Links:
URL
http://www.fondazionedelellis.org
Description
Click here for more information about this study: a similar link (Citomegalovirus - Ricerca per crescere) is included in the home page of this site
Learn more about this trial
Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
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