Cytomegalovirus Congenital InfectionNCT01659684
Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
A study testing standard intravenous immunoglobulin in people with Cytomegalovirus Congenital Infection, run by Fondazione Onlus Camillo De Lellis at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cytomegalovirus Congenital Infection
- What is being tested?
- standard intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women with confirmed primary CMV infection at any stage of gestation.
Who cannot join
- Pregnant women with falsely positive CMV IgM antibodies or high (>40%) CMV IgG avidity indexes
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Infection Disease Unit, Pescara General Hospital, Pescara, Italy
Pescara, Abruzzo, 65124
Francesca D'Arcangelo, MD, francescadarcangelo@yahoo.it
Antonina Sciacca, Secretary, a.sciacca@virgilio.it
About this study
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.
Read the 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.
- Conditions
- Cytomegalovirus Congenital Infection
- Being tested
- standard intravenous immunoglobulin
- Keywords
- congenital CMV infection, standard immunoglobulins, immunoglobulin therapy, IgG CMV avidity index, Cytomegalovirus
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard intravenous immunoglobulinBiological
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection
| Study group | Role | What they receive |
|---|---|---|
| standard intravenous immunoglobulin | Experimental | Single arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls. Receives: Biological: standard intravenous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of neurological damage due to Cytomegalovirus congenital infection
Number of infected newborns with neurological deficits divided by the total number of infected newborns
Measured: Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue
Secondary outcomes (1)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startOct 2010
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus Congenital InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Onlus Camillo De Lellis
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Abruzzo, Italy, Azienda Sanitaria Locale di Pescara
- Responsible party
- Principal investigator, Dr. Giustino Parruti, Azienda Sanitaria Locale di Pescara
- Investigators
- Giustino Parruti, MD, PhD, Principal investigator, Azienda Sanitaria Locale di Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659684
- Sponsor's protocol ID
- IVIG-001
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT01659684
- Acronym / sponsor ID
- IVIG-001
- Conditions
- Cytomegalovirus Congenital Infection
- Keywords
- congenital CMV infection, standard immunoglobulins, immunoglobulin therapy, IgG CMV avidity index, Cytomegalovirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Onlus Camillo De LellisUniversity, hospital or other
- Collaborators
- Regione Abruzzo, Italy, Azienda Sanitaria Locale di Pescara
- Study start
- Oct 2010
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standard intravenous immunoglobulin | Experimental | Biological: standard intravenous immunoglobulinSingle arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women with confirmed primary CMV infection at any stage of gestation.
Key exclusion criteria (1 listed)
- Pregnant women with falsely positive CMV IgM antibodies or high (>40%) CMV IgG avidity indexes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard intravenous immunoglobulinHuman standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection | Biological | standard intravenous immunoglobulin |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Click here for more information about this study: a similar link (Citomegalovirus - Ricerca per crescere) is included in the home page of this siteLink provided by the sponsor.
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Cytomegalovirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Infection Disease Unit, Pescara General Hospital, Pescara, Italy
Pescara, Italy
Giustino Parruti, MD, PhD principal investigator
Azienda Sanitaria Locale di Pescara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard intravenous immunoglobulin in people with Cytomegalovirus Congenital Infection, run by Fondazione Onlus Camillo De Lellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.