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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)
EU CTIS ID: 2023-505818-16-00
What this study is testing
To demonstrate the superiority of a 3-week course of a ceftriaxone+metronidazole treatment followed by 3 weeks of a rifampicin+moxifloxacin+metronidazole combination, then 6 weeks of rifampicin+moxifloxacin (experimental treatment) over a 12-week course of tetracycline-derivative (control treatment) in patients with Hurley stage 2 HS (Hidradenitis suppurativa) at week 12.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults < 60 years old
- Available laboratory blood test performed within the last 2-months.
- 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 and iii) at least one active lesion at inclusion, i.e. inflammatory/suppurative
- Clinical severity of HS at inclusion: Hurley stage 2
- BMI < 35
You likely can't join if
- Person < 18 and ≥ 60 years old
- Immune suppression (including history of any cancer ≤ 5 years), inflammatory disease, including gastroenterologic and rheumatologic inflammatory conditions, or on biological treatment during the month preceding the inclusion
- Alcohol-dependants patients defined as an addiction to alcohol with a negative impact on health, social or personal life
- Lactase deficiency, lactose and galactose intolerance
- Malabsorption syndrome
- Person living in the same household as another patient
See the full eligibility criteria
- Adults < 60 years old
- Available laboratory blood test performed within the last 2-months.
- 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 and iii) at least one active lesion at inclusion, i.e. inflammatory/suppurative
- 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
- Person < 18 and ≥ 60 years old
- Immune suppression (including history of any cancer ≤ 5 years), inflammatory disease, including gastroenterologic and rheumatologic inflammatory conditions, or on biological treatment during the month preceding the inclusion
- Alcohol-dependants patients defined as an addiction to alcohol with a negative impact on health, social or personal life
- 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
- Former stage 3 HS
- Previous use of antibiotics within the last 3 weeks preceding the inclusion
- Previous use of the experimental treatment
- Unauthorized drugs for the study preceding the inclusion
- Any contra-indication to study treatments or excipient (e.g. lactose, cornstarch, riboflavin notably): - pregnancy, breastfeeding, - Patients with potential cross allergy to ceftriaxone (allergy already known to penicillin) - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.