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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
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
DRUG	Lymecyclin and corresponding placebos of the experimental arm	12-week course of oral lymecycline.

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-02-28
• Completion: 2028-02-27
• First posted: 2023-04-20
• Last updated: 2025-07-09

Locations

4 sites across 1 country: France