Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
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| ClinicalTrials.gov Identifier: NCT01659684 |
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Recruitment Status : Unknown
Verified August 2012 by Dr. Giustino Parruti, Azienda Sanitaria Locale di Pescara.
Recruitment status was: Recruiting
First Posted : August 8, 2012
Last Update Posted : August 8, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cytomegalovirus Congenital Infection | Biological: standard intravenous immunoglobulin | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection |
| Study Start Date : | October 2010 |
| Estimated Primary Completion Date : | November 2014 |
| Estimated Study Completion Date : | November 2014 |
| Arm | Intervention/treatment |
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Experimental: standard intravenous immunoglobulin
Single arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls.
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Biological: standard intravenous immunoglobulin
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection |
- 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 ]Number of infected newborns with neurological deficits divided by the total number of infected newborns
- 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 ]Number of women with symptoms or adverse events during infusions divided by the total number of treated women
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659684
| 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 | |
| Principal Investigator: | Giustino Parruti, MD, PhD | Azienda Sanitaria Locale di Pescara |
| Responsible Party: | Dr. Giustino Parruti, MD, PhD, Azienda Sanitaria Locale di Pescara |
| ClinicalTrials.gov Identifier: | NCT01659684 |
| Other Study ID Numbers: |
IVIG-001 |
| First Posted: | August 8, 2012 Key Record Dates |
| Last Update Posted: | August 8, 2012 |
| Last Verified: | August 2012 |
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congenital CMV infection standard immunoglobulins immunoglobulin therapy IgG CMV avidity index Cytomegalovirus |
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Infections Communicable Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Disease Attributes Pathologic Processes Virus Diseases |
Immunoglobulins Immunoglobulins, Intravenous Antibodies gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |