NCT05855889

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
144mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Mar 2023Mar 2038

Study Start

First participant enrolled

March 9, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2031

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2038

Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

8.1 years

First QC Date

April 5, 2023

Last Update Submit

May 19, 2023

Conditions

Congenital Cmv

Outcome Measures

Primary Outcomes (7)

  • Measuring cases of cCMV in the UK

    To analyze the epidemiology of children born with cCMV

    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)

    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

    15 years

  • Adverse events

    To document adverse events of different treatment strategies

    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

    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

    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

    15 years

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Through confirmed detection of CMV in urine or saliva, by CMV-DNA PCR (or viral culture / Shell-vial) and/or CMV detection in blood or CSF by PCR within the first 21 days of life.
  • Children with cCMV retrospectively diagnosis by positive CMV-DNA PCR in dried blood spots (DBS), collected within 21 days of life.
  • Diagnosed by positive CMV-DNA PCR in dried umbilical cord blood or donated/stored umbilical cord blood sample
  • Children whose parents give their informed consent to participate in the study
  • Age less than 11 years old

You may not qualify if:

  • Refusal to sign written informed consent of parents/ legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's University of London

London, SW17 0RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Simon Drysdale, MD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sana Ibrahim, BSc

CONTACT

+44 (0)208 725 5382sibrahim@sgul.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 12, 2023

Study Start

March 9, 2023

Primary Completion (Estimated)

March 30, 2031

Study Completion (Estimated)

March 30, 2038

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

GB(1)