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

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What is this study about?

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.

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.

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.

3 experimental treatment phase 2

For the next 3 weeks, participants will take a combination of rifampicin, moxifloxacin, and metronidazole orally.

4 experimental treatment phase 3

For the final 6 weeks, participants will continue with a combination of rifampicin and moxifloxacin taken orally.

5 control treatment

Participants in the control group will receive a tetracycline derivative for the entire 12-week period. This medication is taken orally.

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 Study?

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 Study?

Patients with Hurley stage 2 active Hidradenitis Suppurativa cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Institut Pasteur	Paris	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Cwk Db Rbvng	Bois-Guillaume	France
Aleebqrtpq Pzgwuuyv Hjdbktqm Dl Mtgqdooop	Marseille	France
Gir Gutlvh hgtnahnbari Pruon Sfeopnctldoy	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.11.2024

Trial locations

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.

Investigated diseases:

Hidradenitis

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.

Trial ID:

2023-505818-16-00

Protocol code:

2018-018

NCT ID:

NCT05821478

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?