[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hsv-throat-reactivation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hsv-throat-reactivation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100532791","preemptive-treatment-with-acyclovir-in-intubated-and-mechanically-ventilated-patients-with-herpes-pth2-100532791",false,"NCT06217406","Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes (PTH2)","Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation and One or Less Organ Failure","PTH2","Inclusion Criteria:\n\n* aged ≥ 18 year-old\n* invasive mechanical ventilation(MV) for 96 hours and planned to last for at least 48 hours longer\n* HSV reactivation in the throat (qualitative PCR positive for HSV on a throat swab)\n* Presence of 1 or less organ failure; organ failure being defined as a corresponding-organ SOFA score of 3 or 4 (for example, renal failure will be defined as a renal SOFA score of 3 or 4)\n* Effective contraception for patients of childbearing age, throughout the treatment period\n* Written consent from the patient, from a close relative or from the person of trust previously appointed (or inclusion procedure in emergency situations)\n* Under social security cover\n\nExclusion Criteria:\n\n* Hypersensitivity to acyclovir and excipient\n* Pregnant or breastfeeding (controlled by a blood pregnancy test)\n* Patient who received an antiviral drug active against HSV (acyclovir, valacyclovir, gancyclovir, valgancyclovir, foscavir, cidofovir) in the previous 30 days\n* Duration of ventilation before randomization \\>15 days\n* Neutropenia, defined by an absolute neutrophils count \\\u003C 1,000\u002Fmm3\n* Solid organ or bone-marrow transplant\n* Immunosuppressive treatment (including steroids at a dose \\>0.5 mg\u002Fkg\u002Fday of prednisone or equivalent for \\>1 month)\n* HIV infection\n* Moribund, defined by a Simplified Acute Physiology Score (SAPS) II score at inclusion \\>75 points\n* Decision of withholding\u002Fwithdrawing care","ALL","18 Years",{"count":20,"type":21},246,"ESTIMATED","INTERVENTIONAL",[24],"NA","This research aims to assess the interest of preemptive treatment with Acyclovir in mechanically ventilated patients with reactivation of Herpes simplex (HSV) in the throat and failure of one organ or less. HSV reactivation is common in patients hospitalized in an intensive care unit (ICU) on invasive mechanical ventilation. It begins at the oropharyngeal level (incidence up to 20-50%), then progresses downward with contamination of the distal airways (reported incidence of 20-65%). HSV reactivation is associated with high mortality. The investigators aim to disable that, in mechanically ventilated patients with HSV reactivation in the throat and failure of one organ or less, preemptive treatment with Acyclovir may reduce mortality.\n\nTo answer the question posed in the research, it is planned to include 246 people hospitalized in intensive care on invasive mechanical ventilation, presenting with HSV reactivation of the throat and one organ failure or less.",[27,28],"Invasive Mechanical Ventilation","HSV Throat Reactivation",[30,31,32,33,34],"ICU","invasive mechanical ventilation","HSV","Acyclovir","Preemptive treatment","NOT_YET_RECRUITING","2024-01-19",{"date":38,"type":39},"2024-01-22","ACTUAL",{"date":41,"type":21},"2024-03-01",{"date":43,"type":21},"2027-03-01",{"name":45,"class":46},"Assistance Publique - Hôpitaux de Paris","OTHER"]