Congenital CmvcCMVnetNCT05855889
Observational Study of the Management of Infants With Congenital CMV
An observational study of Congenital Cmv, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Congenital Cmv
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2023to 30 Mar 2038
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children will be identified at their routine healthcare attendance at the specialist clinics for children with congenital CMV at one of the participating centres. The person with parental responsibility will be approached to be informed about the registry and to request consent, either by the cCMVNET clinician or a delegated research nurse.
Who may be able to join
None listed.
Who cannot join
- Refusal to sign written informed consent of parents/ legal guardian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St George's University of London
London, SW17 0RE
Sana Ibrahim, BSc, +44 (0)208 725 5382, sibrahim@sgul.ac.uk
About this study
This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.
Read the detailed description
Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. It is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. Clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. Screening of congenital CMV infection (cCMV) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with cCMV in physical exams).
The main focus of the study is to identify patient and treatment characteristics that are associated with outcome. This will allow improved patient care in the future.
- Conditions
- Congenital Cmv
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring cases of cCMV in the UK
To analyze the epidemiology of children born with cCMV
Measured: 15 years
Clinical characteristics
To analyze the clinical characteristic of children born with cCMV (measure is number of participants with hearing loss, retinitis, neurological abnormalities, skin rashes, or hepatosplenomegaly)
Measured: 15 years
To evaluate risk factors in children with cCMV for long term sequelae
To measure the number of cases with abnormal brain imaging (cranial USS or MRI), hearing loss, retinitis or anaemia, leucopenia, thrombocytopenia, renal function or liver abnormalities at diagnosis
Measured: 15 years
Adverse events
To document adverse events of different treatment strategies
Measured: 15 years
To evaluate the prognostic value of microbiological variables
To measure the urine CMV viral load in cases at diagnosis who develop hearing loss
Measured: 15 years
To evaluate the prognostic value of image findings
To measure the number of cases who have abnormal brain imaging (cranial USS or MRI) at diagnosis and develop hearing loss
Measured: 15 years
To evaluate associated outcomes with different treatment strategies
To measure the number of cases treated with valganciclovir and the number of treated cases who need a treatment break
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start9 Mar 2023
- Primary completion30 Mar 2031 (estimated)
- Study completion30 Mar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CmvStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Paediatric Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Simon Drysdale, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855889
- Sponsor's protocol ID
- 2021.0118
- Acronym
- cCMVnet
- Status last verified
- May 2023
- First submitted
- 5 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Management of Infants With Congenital CMV
- ClinicalTrials.gov ID
- NCT05855889
- Acronym / sponsor ID
- cCMVnet / 2021.0118
- Conditions
- Congenital Cmv
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- European Society for Paediatric Infectious Diseases
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Mar 2031 (estimated)
- Study completion
- 30 Mar 2038 (estimated)
- First posted
- 12 May 2023 (actual)
- 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.
This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.
Detailed description
Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. It is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. Clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. Screening of congenital CMV infection (cCMV) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with cCMV in physical exams).
The main focus of the study is to identify patient and treatment characteristics that are associated with outcome. This will allow improved patient care in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children will be identified at their routine healthcare attendance at the specialist clinics for children with congenital CMV at one of the participating centres. The person with parental responsibility will be approached to be informed about the registry and to request consent, either by the cCMVNET clinician or a delegated research nurse.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Refusal to sign written informed consent of parents/ legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring cases of cCMV in the UK
Time frame: 15 years
To analyze the epidemiology of children born with cCMV
Clinical characteristics
Time frame: 15 years
To analyze the clinical characteristic of children born with cCMV (measure is number of participants with hearing loss, retinitis, neurological abnormalities, skin rashes, or hepatosplenomegaly)
To evaluate risk factors in children with cCMV for long term sequelae
Time frame: 15 years
To measure the number of cases with abnormal brain imaging (cranial USS or MRI), hearing loss, retinitis or anaemia, leucopenia, thrombocytopenia, renal function or liver abnormalities at diagnosis
Adverse events
Time frame: 15 years
To document adverse events of different treatment strategies
To evaluate the prognostic value of microbiological variables
Time frame: 15 years
To measure the urine CMV viral load in cases at diagnosis who develop hearing loss
To evaluate the prognostic value of image findings
Time frame: 15 years
To measure the number of cases who have abnormal brain imaging (cranial USS or MRI) at diagnosis and develop hearing loss
To evaluate associated outcomes with different treatment strategies
Time frame: 15 years
To measure the number of cases treated with valganciclovir and the number of treated cases who need a treatment break
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
Simon Drysdale, MD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cmv, run by St George's, University of London at 1 site in United Kingdom.
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 0 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: looking for participants now, as of the sponsor's last update on 23 May 2023. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sana Ibrahim, BSc (+44 (0)208 725 5382, sibrahim@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring cases of cCMV in the UK (time frame: 15 years). The study lists 7 primary outcomes in all. 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 23 May 2023.