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:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT04448392
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent from parent(s) or legal guardian(s)
* Confirmation of HSV infection from surface culture/PCR, skin lesion culture/PCR, blood PCR, or CSF PCR (performed at UAB Virology lab)
* ≥34 weeks gestational age at birth
* Weight at study enrollment is ≥ 2000 grams
* Receiving intravenous acyclovir, prescribed by the patient's physician for ≤ 14 days
* ≤ 42 days of age at initiation of parenteral acyclovir
* Creatinine ≤ 1.2
Exclusion Criteria:
* Imminent demise
* Current receipt of other investigational drugs
* Major congenital anomaly that in the site investigator's opinion may impact drug metabolism or the patient's volume of distribution
* Creatinine of \> 1.2 prior to initiation of valacyclovir
* Evidence of immunosuppression (HIV infected, immune deficiencies, etc.)
* Any condition that, in the opinion of the investigator, would place the subject at an unacceptable injury risk or that may interfere with successful study completion
* \> 42 days of age at initiation of parenteral acyclovir
* Concern for parental/guardian compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
12 Weeks
Study:
NCT04448392
Study Brief:
Protocol Section:
NCT04448392