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

Sponsor
Institut Pasteur
Study ID
NCT05821478
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy — DRUG
    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
  • Lymecyclin and corresponding placebos of the experimental arm — DRUG
    12-week course of oral lymecycline.

Study Details

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

Key Dates

First listed
Apr 20, 2023
Start date
May 22, 2025
Status verified
Jul 2025
Primary completion
Feb 28, 2027
Completion
Feb 27, 2028

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental treatment
    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
  • Active Comparator: Control
    12-week course of oral lymecycline (Tetralysal daily dose 452mg) Placebos for all experimental drugs will also be administered during this intensive treatment phase

Primary Outcome Measure

Percentage of patients reaching clinical remission at week 12, defined by an improvement of 90% of the IHS4 score from the baseline (IHS4 (1)) [ Time Frame: at week 12 ]

Central Contacts

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