Congenital Cytomegalovirus: Efficacy of Antiviral Treatment (CONCERT 2)
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| ClinicalTrials.gov Identifier: NCT02005822 |
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Recruitment Status :
Completed
First Posted : December 9, 2013
Last Update Posted : June 3, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Cytomegalovirus Infection Sensorineural Hearing Loss | Drug: Valganciclovir | Phase 3 |
In the Netherlands all neonates are routinely screened for hearing during the first weeks after birth with the Otoacoustic Emissions (OAE) procedure. After the second refer an Automated Auditory Brainstem Response (AABR) is performed. The parents of all newborns, born at ≥ 37 weeks gestational age, that fail this AABR in the Netherlands (about 550 yearly) will be asked for consent for CMV-testing on the dried blood spots. Newborns diagnosed with congenital CMV and with confirmed SNHL (≥ 20 dB) are eligible for inclusion. After informed consent infants will be offered treatment before the age of 13 weeks (6 weeks valganciclovir 32 mg/kg daily dose; oral solution). Parents may decide to participate in the trial in the control group (no antiviral treatment). Infants will be monitored for leucopenia and liver- and kidney function. Inclusion will continue for at least 1.5 years, or until at least 40 infants have been included in the trial.
At age 20 months hearing and child development are assessed in the follow-up. Hearing will be assessed with Brainstem Evoked Response Audiometry with the Vivosonic Integrity. Child development will be assessed with the Bayley Scales of Infant Development III (official Dutch translation) and parents will fill in the Dutch Child Development Inventory (NCDI) which will give more detailed information on communicative development of their child. The hearing assessment and developmental examination will be fulfilled during a home visit. Viral loads in blood and urine will be monitored during antiviral treatment as well as twice in the control group.
This study will provide information on the percentage of infants with a congenital CMV infection who fail the neonatal hearing screening . The trial will show whether early treatment of congenital CMV infected children with hearing impairment prevents deterioration of hearing loss and to what extent. The outcome may lead to implementation of congenital CMV testing in the neonatal hearing screening program or possibly into the newborn blood screening.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Leiden CONCERT Study 2.0 Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Non-Randomized Trial With Historical Control Group |
| Actual Study Start Date : | October 22, 2013 |
| Actual Primary Completion Date : | May 17, 2018 |
| Actual Study Completion Date : | May 17, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Valganciclovir
Valganciclovir 32 mg/kg per day in two doses (16 mg/kg per dose) during 6 weeks in an oral solution.
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Drug: Valganciclovir
Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.
Other Names:
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No Intervention: Control
Refusal control group: Infants in the control group receive no antiviral therapy. Counseling and treatment assigned by an audiological center remain unchanged. Historical control group: Infants with birth date 1-11-2011 till 1-07-2012 with sensorineural hearing loss and congenital CMV. |
- Hearing assessment [ Time Frame: Age: 20 months ]At 20 months of age hearing will be assessed with Brainstem Evoked Response Audiometry using the Vivosonic Integrity during a home visit.
- Child development [ Time Frame: Age: 20 months ]At age 20 months child development will be assessed during a home visit with the Bayley Scales of Infant Development III (official Dutch translation). Additionally, parents will fill in the Dutch Child Development Inventory.
- Viral load [ Time Frame: Baseline, weekly during 7 weeks, and at 20 months of age ]
Viral blood load will be monitored in the treatment group(at baseline, weekly during antiviral treatment, and one week after treatment) as well as in the control group (baseline and 7 weeks after inclusion).
Viral urine load will be monitored in the treatment group and in the control group (at baseline, weekly during 7 weeks after inclusion, and at the age of 20 months).
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| Ages Eligible for Study: | 3 Weeks to 12 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005822
| Netherlands | |
| Department Medical Microbiology | |
| Leiden, Zuid Holland, Netherlands, 2300 RC | |
| Study Director: | Ann CTM Vossen, Dr. | Leiden University Medical Center | |
| Principal Investigator: | Anne Marie Oudesluys - Murphy, Prof. Dr. | Leiden University Medical Center |
| Responsible Party: | Dr. Ann C.T.M. Vossen, MD, PhD, Dept of Medical Microbiology, Leiden University Medical Center |
| ClinicalTrials.gov Identifier: | NCT02005822 |
| Other Study ID Numbers: |
CMV-MM-2 2013-003068-30 ( EudraCT Number ) |
| First Posted: | December 9, 2013 Key Record Dates |
| Last Update Posted: | June 3, 2021 |
| Last Verified: | June 2021 |
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Cytomegalovirus Congenital infection Sensorineural hearing loss Valganciclovir |
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Cytomegalovirus Infections Hearing Loss Deafness Hearing Loss, Sensorineural Infections Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders |
Neurologic Manifestations Nervous System Diseases Herpesviridae Infections DNA Virus Infections Virus Diseases Valganciclovir Antiviral Agents Anti-Infective Agents |