Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients
Key facts
- Who runs it
- Institut Pasteur
- Where
- Bois-Guillaume, Écully, Lille, Marseille, Nantes, Paris, Paris Cedex 14, and Rennes, FranceSee the 8 sites
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 92 people, planned
- Started
- 22 May 2025
- Expected to end
- 27 Feb 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy
- Lymecyclin and corresponding placebos of the experimental arm
- Record updated
- 9 July 2025
Who can take part
- Age
- 18 years to 59 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 29 criteriaShow less
Who can take part
- Adults < 60 years old
- Diagnosis of HS according to European Dermatology guidelines:; 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/or scarring; 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)
- Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year
- Clinical severity of HS at inclusion: Hurley stage 2
- BMI < 35
- Written informed consent from patient
- Patient able to complete DLQI
- Patients affiliated to the French health system (Assurance Maladie), except French state medical aid beneficiaries (Aide Médicale d'Etat)
- Active compatible contraception for men and women of childbearing or inability to procreate
- Available laboratory blood test performed within the last 2-months; Non inclusion Criteria:
- Person < 18 and ≥ 60 years old
- Former stage 3 HS
- Previous use of the experimental treatment
- Unauthorized drugs for the study during the month preceding the inclusion
- Any contra-indication to study treatments or excipient (e.g. lactose, cornstarch, riboflavin notably):; pregnancy, 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/kidney dysfunction, porphyria, mandatory use of nonsteroidal anti-inflammatory drugs (NSAIDs) for other medical conditions
- Unbalanced diabetes (ie HbA1c above 7%)
- Dysphagia, untreated gastro-oesophageal reflux/ulcer
- BMI ≥ 35
- Immune suppression, inflammatory disease, including gastroenterologic and rheumatologic inflammatory conditions
- Lactase deficiency, lactose and galactose intolerance
- Malabsorption syndrome
- Person living in the same household as another patient
- Person under guardianship or curatorship
- 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
- Participation in another interventional research on health products studies
- Patients requiring repeated (more than 3/year) use of antibiotics for a chronic disease other than HS
- Alcohol-dependant patients defined as an addiction to alcohol with a negative impact on health, social or personal life
Who cannot take part
- Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin)
- Pregnancy 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 59 years old?
Where in France
- CHU De RouenBois-Guillaume, FranceTaking people
- Clinique du Val d'OuestÉcully, FranceTaking people
- CHU de LilleLille, FranceTaking people
- Assistance Publique Hôpitaux de MarseilleMarseille, FranceTaking people
- CHU de Nantes - Hôtel DieuNantes, FranceTaking people
- Institut PasteurParis, FranceTaking people
- GIE Groupe hospitalier Paris Saint-Joseph/VinciParis Cedex 14, FranceTaking people
- CHU de Rennes - Hôpital PontchaillouRennes, FranceTaking people
About the trial
What the trial wants to find out
The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative
The 2 groups in the trial
- Experimental treatmentTreatment being tested
a 3-week course of ceftriaxone (Rocephin) IV injection (daily dose 2g/day) \+ oral metronidazole (daily dose 1500mg) followed by a 3-week course of oral rifampicin (Rifadin with 10mg/kg/day) + moxifloxacin (Izilox daily dose 400mg) + metronidazole (daily dose 1500mg) followed by a 6-week course of oral rifampicin (Rifadin with 10mg/kg/day) + moxifloxacin (Izilox daily dose 400mg). A placebo for lymecycline will also be administered during this intensive treatment phase
Treatment: ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy
- ControlExisting treatment, for comparison
12-week course of oral lymecycline (Tetralysal daily dose 452mg) Placebos for all experimental drugs will also be administered during this intensive treatment phase
Treatment: Lymecyclin and corresponding placebos of the experimental arm
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Fit questions
- Built from NCT05821478, who can take part
- Record updated
- 9 July 2025