CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group

Phase 3

Completed

• Conditions: congenital cytomegalovirus (CMV); 10040792; 10019243; 10012562

• Registration Number: NL-OMON41461
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Treatment group and refusal control group
- Infants with congenital CMV infection, and hearing loss (* 20 dB, in one or both ears).
- Age at time of inclusion is * 12 weeks after birth.
- Born at * 37 weeks gestational age.
- Birth weight > -2 SD corrected for duration of pregnancy and ethnic origin.
- Parental signed informed consent.;Historical control group
- Infants with congenital CMV infection, and hearing loss (* 20 dB, in one or both ears).
- Age at time of inclusion is > 13 weeks after birth.
- Born at * 37 weeks gestational age.
- Birth weight > -2 SD corrected for duration of pregnancy and ethnic origin.
- Parental signed informed consent.

Exclusion Criteria

Treatment group and refusal control group
- Previously noted (* 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested. For
example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin.
- Treatment with other antiviral agents or immunoglobulins.
- Solely applicable for treatment group: leucopenia < 0,5 x 10*9/L (blood sample tested at t=0).;Historical control group
- Previously encountered (* 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin.
- Treatment with (val)ganciclovir.
- Treatment with other antiviral agents or immunoglobulins.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the status of the SNHL expressed in dB, in children<br /><br>with congenital CMV at follow-up (age 18 * 22 months after birth).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Treatment group and refusal & historical control group<br /><br>The secondary endpoint is the development of the infants.<br /><br>Viral load in urine at follow-up.<br /><br><br /><br>Treatment group and refusal control group<br /><br>The viral load (in dried blood spots, blood and urine) will be monitored during<br /><br>the 7 weeks after inclusion. Furthermore, possible resistance to the medication<br /><br>will be analysed.</p><br>