Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT00031434
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent from parent(s) or legal guardian(s).
* Culture confirmation of cytomegalovirus (CMV) from urine or throat swab specimens.
* Symptomatic congenital CMV disease, as manifest by one or more of the following:
Thrombocytopenia Petechiae Hepatomegaly Splenomegaly Intrauterine growth restriction Hepatitis (elevated transaminases and/or bilirubin) Central nervous system involvement of the CMV disease (such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal CSF indices for age, chorioretinitis, hearing deficits as detected by brainstem evoked response, and/or positive CMV PCR from CSF)
* Less than or equal to 30 days of age at study enrollment.
* Weight at study enrollment greater than or equal to 1800 grams.
* Gestational age greater than or equal to 32 weeks.
Exclusion Criteria:
* Imminent demise.
* Patients receiving other antiviral agents or immune globulin.
* Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis).
* Creatinine clearance \< 10mL/min/1.73 square meters at time of study enrollment.
* Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Days
Study:
NCT00031434
Study Brief:
Protocol Section:
NCT00031434