![]() Asymptomatic HSV infection is common in older children but rare in neonates. This probability increases when the infant also has a history of seizures or presents at times when enteroviruses are not reported in the community. HSV may be the causative agent in neonates who present with a fever, a vesicular rash, or abnormal cerebrospinal fluid (CSF) findings. ![]() ![]() Disseminated infection is a consideration when neonates present with sepsis syndrome, negative bacteriologic culture results, severe liver dysfunction, or consumptive coagulopathy in the first 30 days. When skin lesions are not present, it can be challenging to diagnose neonatal HSV infection. Approximately two-thirds of neonates with disseminated or CNS disease have skin lesions, but other symptoms may be present before these lesions can be seen. Those patients without skin vesicles have infection limited to the eyes and/or oral mucosa. More than 80% of neonates with SEM disease have skin vesicles. (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.Disease limited to the skin, eyes, and/or mouth (SEM disease) (45%) Patient using or addicted to recreational drugs.Patient under listed homeopathic or phytotherapy treatment,.Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy,.Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study,.Patient who participated in a clinical study in the previous 3-month period,.Patient with known lactose intolerance,.Patient who wishes to continue his/her suppressive antiviral therapy,.Patient who had a suppressive antiviral therapy during last month,.Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,.Signature of the Informed Consent Form.Patient having faculties to understand and respect the constraints of the study,.Patient reporting a current stable sexual relationship (steady sexual partner during study duration),.Woman of childbearing age under effective contraception,.Patient presenting 4 or more episodes of genital herpes infections during the preceding 12-months' period (prior to the study entry),.Treatment will be considered successful if the number of herpetic episodes is reduced. Group n☁ = 2LHERP® (6 months of treatment) Group n☂ = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. evaluation of impact on the quality of life,.symptomatology during the entire relapse time,.time to first episode during the treatment,.remaining herpes infection recurrence free 6 and 12 months after the treatment initiation,.The total number of patients to include will be 100 with 50 patients per group.Įvaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.Ĭomparison of the efficacy of 2LHERP® vs placebo, according to the following aspects: Patients aged between 18 and 80 years who present recurrent genital herpes infections (4 or more episodes within the 12-months' period prior to their study entry). The study duration will be maximum 45 months with 33 months of inclusion and 12 months of follow-up. Why Should I Register and Submit Results?.
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