Efficacy of antiviral treatment of congenital cytomegalovirus in a non-randomized trial with historical control group

Phase 1

• Conditions: Congenital cytomegalovirus infection.Sensorineural Hearingloss.; MedDRA version: 18.0Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003068-30-NL
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-05
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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 = 2500 gram.
- 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 = 2500 gram.
- Parental signed informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified