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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00006135
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth; HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than 115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative CSF PCR result
Birth weight at least 800 grams
--Prior/Concurrent Therapy--
No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk of herpes simplex virus infection
--Patient Characteristics--
Renal: Creatinine no greater than 1.5 mg/dL
Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage
Other: No infants known to be born to HIV-positive women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
28 Days
Study:
NCT00006135
Study Brief:
Protocol Section:
NCT00006135