The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
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
12-week course of oral lymecycline.
Hôpital de la Timone
Marseille, France
NOT_YET_RECRUITINGCentre Médical de l'Institut Pasteur
Paris, France
RECRUITINGHopital St Joseph
Paris, France
ACTIVE_NOT_RECRUITINGPercentage of patients reaching clinical remission at week 12, defined by an improvement of 90% of the IHS4 score from the baseline (IHS4 (1))
The clinical remission is defined as a 90% improvement of the International Hidradenitis Suppurativa Severity Score (IHS4) at week 12 compared to the baseline. The IHS4 score is a validated composite score developped to assess dynamically HS severity (1). It is calculated by adding the number of inflammatory nodules to the number of abscesses multiplied by 2 and to the number of draining tunnels multiplied by 4. A total score of 3 or less corresponds to mild severity HS, 4-10 to moderate severity HS and 11 or higher to severe disease.
Time frame: at week 12
Change in Physician Global Assessment (PGA)
Physician assessment describe by differents severity : from Clear (no nodule) to Very severe (more than 5 abscesses or fistulas) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52
Time frame: from baseline to week 52
Change in Modified Sartorius score
Score calculated by points from 0 (better) with differents parameters involved such as location / number / size / type of lesions Score evaluated at baseline / week 6 / week 12/ week 24/ week 52
Time frame: from baseline to week 52
Change in Hurley Score
Score described with 3 stages from I (less severity) to III (most severe) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52
Time frame: from baseline to week 52
Change in Hidradenitis Suppurativa Severity Score (IHS4) score
Score calculated by points from \<3pts (Mild) to \> 11pts (Severe) by nb of nodules, nb of abscesses and nb of draining tunnels Score evaluated at baseline / week 6 / week 12/ week 24/ week 52
Time frame: from baseline to week 52
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CHU de Rouen
Rouen, France
Change in Hidradenitis Suppurativa Clinical Response (HiSCR) score
Global Assessment score of clear, minimal, or mild evaluated by (i) at least a 50% reduction in AN (abscess and nodule count), (ii) no increase in the number of abscesses and (iii) no increase in the number of draining fistulas from baseline Score evaluated at baseline / week 6 / week 12/ week 24/ week 52
Time frame: from baseline to week 52
Change in Dermatology Life Quality Index (DLQI) score (Patient's HS evaluation)
Evaluated with the Dermatology Life Quality Index (DLQI) Score calculated by points from 0 to 30 following patient answers on quality of life questions Score evaluated at baseline / week 6 / week 12/ week 24/ week 52
Time frame: from baseline to week 52
Change of patient pain
Intensity of pain evaluated with the visual analog scale (VAS) from 0 (no pain) to 10 (pain as bad as it could possible be) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52
Time frame: from baseline to week 52
Microbiological bacterial Change on the worst lesion microbiome at W12
By identification of microbiology bacterial metagenomics (by skin lesional swab sample)
Time frame: at baseline and week 12
Microbiological metagenomics Change on the worst lesion microbiome at W12
By identification of multidrug resistant bacteria (by rectal swab sample)
Time frame: at baseline and week 12
Number of pain killers received by patients
Number of pain killers prescribed for flares (acute worsening of one or more HS lesions)
Time frame: from baseline to week 52
Number of antibiotic treatments received by patients
Number of antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions)
Time frame: from baseline to week 52
Time without flare of HS
Evaluated by number of flares reported or not using a patient journal
Time frame: from baseline to week 52
Change in BMI
Calculated by combined weight and height measures
Time frame: from baseline to week 52
Abnormal biological value of Hemoglobin
measured in g/L, compared to normal ranges
Time frame: from baseline to week 12
Abnormal biological value of white cells
measured in units of cells / mm3 , compared to normal ranges
Time frame: from baseline to week 12
Abnormal biological value of neutrophils
measured in units of cells / mm3 , compared to normal ranges
Time frame: from baseline to week 12
Abnormal biological value of platelet count
measured in units of cells / mm3 , compared to normal ranges
Time frame: from baseline to week 12
Abnormal value of AST liver enzyme
AST value \> 4 x Upper limit of normal
Time frame: from baseline to week 12
Abnormal value of ALT liver enzyme
ALT value \> 4 x Upper limit of normal
Time frame: from baseline to week 12
Number of adverse events of all kind
AE defined by SOC and PT according to MedDra dictonnary
Time frame: from baseline to week 52
Non complete drug administration
Evaluated by total number of capsules not taken according to patient journal
Time frame: from baseline to week 12