[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":96,"collaborators":98,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":41,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":66,"whyStopped":41,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Institut Pasteur","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental treatment","EXPERIMENTAL","a 3-week course of ceftriaxone (Rocephin) IV injection (daily dose 2g\u002Fday)\n\n\\+ oral metronidazole (daily dose 1500mg) followed by a 3-week course of oral rifampicin (Rifadin with 10mg\u002Fkg\u002Fday) + moxifloxacin (Izilox daily dose 400mg) + metronidazole (daily dose 1500mg) followed by a 6-week course of oral rifampicin (Rifadin with 10mg\u002Fkg\u002Fday) + moxifloxacin (Izilox daily dose 400mg).\n\nA placebo for lymecycline will also be administered during this intensive treatment phase",[13],"Drug: ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","12-week course of oral lymecycline (Tetralysal daily dose 452mg) Placebos for all experimental drugs will also be administered during this intensive treatment phase",[19],"Drug: Lymecyclin and corresponding placebos of the experimental arm",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy","a 3-week course of ceftriaxone injection + oral metronidazole followed by a 3-week course of oral rifampicin + moxifloxacin +metronidazole followed by a 6-week course of oral rifampicin + moxifloxacin",[9],[9],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Lymecyclin and corresponding placebos of the experimental arm","12-week course of oral lymecycline.",[15],[32],"Control treatment",[34],{"name":35,"affiliation":5,"role":36},"Maïa Delage-Toriel, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+33 1 40 61 30 77",null,"maia.delage-toriel@pasteur.fr",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Aude Nassif, MD","01 40 61 30 77","aude.nassif@pasteur.fr",[48,64,78,84],{"facility":49,"status":50,"city":51,"state":41,"zip":41,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hôpital de la Timone","NOT_YET_RECRUITING","Marseille","France","FR",{"type":55,"coordinates":56},"Point",[57,58],5.38107,43.29695,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":41,"phoneExt":41,"email":63},"Marie-Aleth Richard, MD, PhD","MarieAleth.RICHARD@ap-hm.fr",{"facility":65,"status":66,"city":67,"state":41,"zip":41,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Centre Médical de l'Institut Pasteur","RECRUITING","Paris",{"type":55,"coordinates":69},[70,71],2.3488,48.85341,{"lat":71,"lon":70},[74,75],{"name":35,"role":39,"phone":41,"phoneExt":41,"email":42},{"name":76,"role":77,"phone":41,"phoneExt":41,"email":41},"Aude Nassif","SUB_INVESTIGATOR",{"facility":79,"status":80,"city":67,"state":41,"zip":41,"country":52,"countryCode":53,"cosmosGeoPoint":81,"geoPoint":83,"contacts":41},"Hopital St Joseph","ACTIVE_NOT_RECRUITING",{"type":55,"coordinates":82},[70,71],{"lat":71,"lon":70},{"facility":85,"status":50,"city":86,"state":41,"zip":41,"country":52,"countryCode":53,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"CHU de Rouen","Rouen",{"type":55,"coordinates":88},[89,90],1.09932,49.44313,{"lat":90,"lon":89},[93],{"name":94,"role":39,"phone":41,"phoneExt":41,"email":95},"Anne-Bénédicte Duval-Modeste, Dr","AB.Duval-Modeste@chu-rouen.fr",{"type":97,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[99,102,104,107],{"name":100,"class":101},"Centre Hospitalier Universitaire de Caen","OTHER",{"name":103,"class":101},"Hôpital Necker-Enfants Malades",{"name":105,"class":106},"Ministry of Health, France","OTHER_GOV",{"name":108,"class":101},"Assistance Publique Hopitaux De Marseille","100502378","phase-3-efficacy-of-an-adapted-antibiotherapy-in-hurley-stage-2-hidradenitis-suppurativa-patients-100502378",false,"NCT05821478","Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients","A Multicentric Randomized Double-Blind Phase 3 Trial Evaluating the Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Active Hidradenitis Suppurativa Patients Versus Tetracycline Derivative","ABCESS2","Inclusion Criteria:\n\n* Adults \\\u003C 60 years old\n* Diagnosis of HS according to European Dermatology guidelines:\n\n  * Recurrent inflammation occurring more than 2 times in the past 6 months in the inverse regions of the body, presenting with nodules, sinus-tracts and\u002For scarring.\n  * Signs: Involvement of axilla, genitofemoral area, perineum, gluteal area (and infra-mammary areafor women). Presence of nodules (inflamed or noninflamed), sinus tracts (inflamed or noninflamed), abscesses, scarring (atrophic, mesh-like, red, hypertrophic or linear)\n* Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year\n* Clinical severity of HS at inclusion: Hurley stage 2\n* BMI \\\u003C 35\n* Written informed consent from patient\n* Patient able to complete DLQI\n* Patients affiliated to the French health system (Assurance Maladie), except French state medical aid beneficiaries (Aide Médicale d'Etat)\n* Active compatible contraception for men and women of childbearing or inability to procreate\n* Available laboratory blood test performed within the last 2-months\n\nNon inclusion Criteria:\n\n* Person \\\u003C 18 and ≥ 60 years old\n* Former stage 3 HS\n* Previous use of the experimental treatment\n* Unauthorized drugs for the study during the month preceding the inclusion\n* Any contra-indication to study treatments or excipient (e.g. lactose, cornstarch, riboflavin notably):\n\npregnancy, breastfeeding, known allergy to experimental or reference drugs, wheat allergy, tendinopathy, QT prolongation, bradycardia, heart failure, heart rhythm disturbances, hydroelectrolytic disorders, hypokalemia, coagulation disorders, severe liver\u002Fkidney dysfunction, porphyria, mandatory use of nonsteroidal anti-inflammatory drugs (NSAIDs) for other medical conditions\n\n* Unbalanced diabetes (ie HbA1c above 7%)\n* Dysphagia, untreated gastro-oesophageal reflux\u002Fulcer\n* BMI ≥ 35\n* Immune suppression, inflammatory disease, including gastroenterologic and rheumatologic inflammatory conditions\n* Lactase deficiency, lactose and galactose intolerance\n* Malabsorption syndrome\n* Person living in the same household as another patient\n* Person under guardianship or curatorship\n* Individuals with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g patient unable to complete DLQI, or poor predictable observance\n* Participation in another interventional research on health products studies\n* Patients requiring repeated (more than 3\u002Fyear) use of antibiotics for a chronic disease other than HS\n* Alcohol-dependant patients defined as an addiction to alcohol with a negative impact on health, social or personal life\n\nExclusion criteria:\n\nPregnancy QT prolongation Abnormal result of routine lab tests corresponding to contra-indication to study treatments Unauthorized drug for the study during all the study (from study treatments interactions listed in the SmPC, Cf. unauthorized drug listed in non-inclusion criteria).\n\nDevelopment of hypersensitivity to any of the study products and\u002For excipients (e.g. lactose, corn starch, riboflavin).","ALL","18 Years","59 Years",{"count":121,"type":122},92,"ESTIMATED","INTERVENTIONAL",[125],"PHASE3","The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative",[128],"Hidradenitis Suppurativa",[128,130,131],"Antibioresistance","Antibiotherapy","2025-07-03",{"date":134,"type":135},"2025-07-09","ACTUAL",{"date":137,"type":135},"2025-05-22",{"date":139,"type":122},"2028-02-27",{"name":5,"class":6},4]