Congenital cytomegalovirus (CMV) infection Infections and Infestations
Conditions
Interventions
Participants enrolling in this retrospective follow-up study will have audiologic and neurodevelopmental assessments obtained, as well as assessments for long-term endocrine (pubertal) and oncologic t
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent from the participant, the parent(s) or legal guardian(s), with signed assent from the participant (as appropriate) 2. =2 years old to <16 years old 3. One of the following: 3.1. Prior receipt of intravenous ganciclovir or oral valganciclovir for the clinical treatment of congenital CMV infection by clinicians at a current or former CASG study site OR 3.2. Prior receipt of intravenous ganciclovir or oral valganciclovir through participation in a CASG study of the treatment of congenital CMV
Exclusion criteria
Exclusion criteria: Unable to comply with study-related procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total ear hearing assessments since completion of antiviral therapy, adjusted for age at initiation of therapy and time since completion of therapy. This is measured through a hearing assessment on a single study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in best ear hearing assessments since completion of antiviral therapy, adjusted for age at initiation of therapy and time since completion of therapy. This is measured through a hearing assessment (either, traditional, play, Visual Reinforcement Audiometry, or otoacoustic emission testing and/or auditory brainstem response) on a single study visit. 2. Neurodevelopmental assessment at the time of the single study visit. This is a measure through neurodevelopment assessment (tailored to participants’ abilities and age: either WPPSI-IVUK, WISC-VUK, Leither-3, or Bayley-4) on a single study visit. 3. Any development of cancer before the single study visit. This data is collected from the participant as medical history on a single study visit. 4. Pubertal development (delayed, age-appropriate, advanced) at the time of the single study visit. This data is collected from the participant as medical history and physical exam on a single study visit. Exploratory endpoints: 1. Cell-mediated immunity against CMV. This is measured on a blood sample (T-SPOT.CMV assay) at the time of the single study visit. 2. CMV genotypes. This is measured from blood, urine, and saliva samples (viral load by PCR) at the time of the single study visit. 3. Ganciclovir resistance mutations in CMV-positive blood, urine, and saliva samples at the time of the single study visit (if the viral load is sufficiently elevated by Next Generation Sequencing). | — |
Countries
England, United Kingdom
Contacts
Public ContactSimon Drysdale
Outcome results
None listed