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Study on the Effectiveness of Ceftriaxone and Metronidazole Combination for Patients with Hurley Stage 2 Hidradenitis Suppurativa

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a skin condition called Hidradenitis Suppurativa, specifically in patients with a moderate stage known as Hurley stage 2. The study aims to evaluate the effectiveness of a new treatment approach compared to a standard treatment. The new treatment involves a combination of medications: ceftriaxone and metronidazole for the first three weeks, followed by a combination of rifampicin, moxifloxacin, and metronidazole for the next three weeks, and finally, rifampicin and moxifloxacin for the last six weeks. The standard treatment being compared is a 12-week course of a medication similar to tetracycline, which is commonly used to treat this condition.

Participants in the study will be randomly assigned to receive either the new treatment or the standard treatment. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment is being given to each participant. This helps ensure that the results are not biased. The study will last for a total of 12 weeks, during which participants will be monitored for improvements in their condition. The main goal is to see if the new treatment is more effective in achieving remission, which means a significant reduction in the symptoms of Hidradenitis Suppurativa.

Throughout the study, participants will have regular check-ups to assess their progress. These check-ups will include evaluations of the skin condition, as well as monitoring for any side effects from the treatments. The study will also look at other factors, such as the quality of life and the number of flare-ups, which are periods when the condition worsens. The results of this study could provide valuable information on the best treatment options for people with Hurley stage 2 Hidradenitis Suppurativa.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the trial, participants will be randomly assigned to one of two groups. One group will receive the experimental treatment, and the other will receive the control treatment.
Step 2
Experimental treatment phase 1
For the first 3 weeks, participants in the experimental group will receive a combination of ceftriaxone and metronidazole. Ceftriaxone is administered as an injection, while metronidazole is taken orally.
Step 3
Experimental treatment phase 2
For the next 3 weeks, participants will take a combination of rifampicin, moxifloxacin, and metronidazole orally.
Step 4
Experimental treatment phase 3
For the final 6 weeks, participants will continue with a combination of rifampicin and moxifloxacin taken orally.
Step 5
Control treatment
Participants in the control group will receive a tetracycline derivative for the entire 12-week period. This medication is taken orally.
Step 6
End of the trial
At the end of the 12-week period, participants will undergo evaluations to assess the effectiveness of the treatment. This includes measuring the improvement in the condition and any side effects experienced.

Who can join the trial?

9 criteria

Adults under 60 years old
Recent blood test available from the last 2 months
Diagnosis of Hidradenitis Suppurativa (HS) according to European Dermatology guidelines: This means having repeated inflammation more than twice in the past 6 months in certain areas of the body, with symptoms like lumps, tunnels under the skin, and/or scarring. Affected areas can include the armpits, groin, genital area, buttocks, and under the breasts for women. Symptoms include lumps (inflamed or not), tunnels (inflamed or not), abscesses, and different types of scarring.
Active HS for at least 1 year with at least 4 flare-ups in the past year
HS severity at the time of joining the study should be Hurley stage 2
Body Mass Index (BMI) less than 35
Written informed consent from the patient
Ability to complete the Dermatology Life Quality Index (DLQI), a questionnaire about the impact of skin disease on life
Active and suitable contraception for men and women who can have children, or inability to have children

Who cannot join the trial?

1 criterion

Patients with **Hurley stage 2 active Hidradenitis Suppurativa** cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Assistance Publique Hopitaux De Marseille
Marseille, France
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CHU De Rouen
Bois-Guillaume, France
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Centre Hospitalier Universitaire De Lille
Lille, France

Trial locations

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Investigated drugs

Ceftriaxone
is an antibiotic used to treat a wide variety of bacterial infections. In this trial, it is part of the initial treatment phase to help reduce the infection and inflammation associated with Hidradenitis Suppurativa, a skin condition.
Metronidazole
is another antibiotic that works by stopping the growth of bacteria. It is used in combination with other antibiotics in this trial to enhance the treatment's effectiveness against the skin condition.
Rifampicin
is an antibiotic that is often used to treat infections caused by bacteria. In this trial, it is used in combination with other antibiotics to help manage the symptoms of Hidradenitis Suppurativa by reducing bacterial growth.
Moxifloxacin
is an antibiotic that helps to kill bacteria and is used in this trial as part of a combination therapy. It aims to improve the condition of the skin by targeting the bacteria causing the infection.
Tetracycline Derivative
is a type of antibiotic that is used as a control treatment in this trial. It works by stopping the growth of bacteria and is commonly used to treat various infections, including those affecting the skin.

What is already known about the treatment

Ceftriaxone
Ceftriaxone is administered as an injection, typically given into a vein or muscle. It is currently used in medicine as a broad-spectrum antibiotic to treat various bacterial infections. In this trial, it is part of a combination therapy for Hurley stage 2 active Hidradenitis Suppurativa. Ceftriaxone works by interfering with the bacteria's ability to form cell walls, which are essential for their survival. It belongs to the pharmacological class of cephalosporin antibiotics.
Metronidazole
Metronidazole is usually taken orally in tablet form or administered intravenously. It is widely used in medicine to treat infections caused by anaerobic bacteria and certain parasites. In this trial, it is used in combination with other antibiotics for treating Hurley stage 2 active Hidradenitis Suppurativa. Metronidazole works by entering the bacterial cell and disrupting its DNA, leading to cell death. It is classified as a nitroimidazole antibiotic.
Rifampicin
Rifampicin is typically taken orally in capsule form. It is a well-known antibiotic used to treat several types of bacterial infections, including tuberculosis. In this trial, it is part of a combination therapy for Hurley stage 2 active Hidradenitis Suppurativa. Rifampicin works by inhibiting the bacterial RNA polymerase, which is crucial for bacterial RNA synthesis. It belongs to the pharmacological class of rifamycin antibiotics.
Moxifloxacin
Moxifloxacin is administered orally in tablet form or as an intravenous infusion. It is used in medicine to treat a variety of bacterial infections, particularly those affecting the respiratory tract. In this trial, it is used in combination with other antibiotics for Hurley stage 2 active Hidradenitis Suppurativa. Moxifloxacin works by inhibiting bacterial enzymes necessary for DNA replication and repair. It is classified as a fluoroquinolone antibiotic.
Tetracycline Derivative
Tetracycline derivatives are usually taken orally in capsule or tablet form. They are commonly used to treat a wide range of bacterial infections. In this trial, a tetracycline derivative serves as the control treatment for Hurley stage 2 active Hidradenitis Suppurativa. These antibiotics work by preventing bacteria from producing proteins necessary for their growth and reproduction. They belong to the pharmacological class of tetracycline antibiotics.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the development of painful, inflamed nodules, abscesses, and sinus tracts, primarily in areas where skin rubs together, such as the armpits, groin, and under the breasts. The disease progresses through stages, with Hurley stage 2 involving recurrent abscesses with sinus tract formation and scarring. Over time, these lesions can become interconnected, leading to more extensive scarring and skin changes. The condition often begins after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.