Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients (ABCESS2)

Pasteur Institute

Status and phase: Not yet enrolling; Phase 3

Conditions: Hidradenitis Suppurativa

Treatments: Drug: ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy; Drug: Lymecyclin and corresponding placebos of the experimental arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05821478

2018-018

Details and patient eligibility

About

The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative

Full description

The antibiotic strategy is targeted against specific pathobionts which have been identified in HS lesions by the investigator's team.

Half of participants will receive a 3-week course of ceftriaxone + metronidazole treatment followed by 3 weeks of rifampicin + moxifloxacin + metronidazole combination, then 6 weeks of rifampin + moxifloxacin (experimental groupe), versus a 12 weeks course of lymecycline (control group) Double blind treatment phase will stop at week 12. All patients whatever their randomization arm or their remission status will begin follow-up treatment according to standard care recommendations (Société Française de Dermatologie): lymecycline, doxycycline or cotrimoxazole. Prescription will be upon decision of the investigator.

This maintenance treatment is not experimental.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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).

Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups

Experimental treatment

Experimental group

Description:

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:

Drug: ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy

Control

Active Comparator group

Description:

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:

Drug: Lymecyclin and corresponding placebos of the experimental arm