Centre Hospitalier De Pau
Pau, France
Not recruitingBartonellosis
Study on Gentamicin and Azithromycin for Treating Lymph Node Infection in Cat Scratch Disease Patients
Verified siteRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial focuses on the treatment of a condition known as cat scratch disease, which can cause swollen and painful lymph nodes, a condition referred to as lymphadenitis. The study is investigating the effectiveness of an injection of a medication called gentamicin directly into the lymph nodes. This is being compared to a placebo to see if it helps improve the condition over a period of 28 days. Participants in the study will also be treated with an oral antibiotic called azithromycin, which is commonly used to treat infections.
The purpose of the study is to determine if the injection of gentamicin can lead to a better outcome for patients with suppurative cat scratch disease's lymphadenitis, which is a form of the disease where the lymph nodes become filled with pus. The study will monitor the reduction in the size of the lymph nodes and the need for additional medical procedures, such as needle aspirations or surgery, over the course of the study.
Participants will be observed for changes in their condition, including the size of the lymph nodes and the level of pain experienced. The study will also assess the safety of the gentamicin injection and monitor for any potential resistance to the antibiotics used. The trial aims to provide valuable information on whether this treatment approach can offer a more effective solution for managing this condition.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- Must be an adult who is 18 years old or older.
- Must provide informed consent, which means agreeing to participate after understanding the study details.
- Must have suppurated cat-scratch disease's adenitis. This is a condition where the lymph nodes are swollen and filled with pus, confirmed by an ultrasound test and a blood test showing positive results for certain antibodies (IgG and/or IgM) against a bacteria called B. henselae.
- Must be affiliated with the French Social Security System, meaning you are part of the healthcare system in France.
Who cannot join the trial?
5 criteria
- Patients who are not diagnosed with **Bartonellosis**. This is an infection caused by bacteria from the Bartonella family.
- Patients who are not experiencing **suppurative cat scratch disease's lymphadenitis**. This is a condition where the lymph nodes, which are small glands in the body, become swollen and filled with pus due to an infection from a cat scratch.
- Patients who are not being treated with **oral azithromycin**. This is a type of antibiotic medication used to treat infections.
- Patients who are not within the specified age range for the study.
- Patients who are part of a vulnerable population, which means they might need special protection or care.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Verified Centre Hospitalier De Perigueux
Perigueux, FranceVerified Centre Hospitalier Departemental Vendee
La Roche sur Yon, France
Trial locations
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Investigated drugs
Gentamicin
is an antibiotic used in this trial to treat lymphadenitis caused by cat scratch disease. It is administered directly into the lymph nodes to target the infection more effectively.
Azithromycin
is another antibiotic used in this study. It is taken orally and works by stopping the growth of bacteria, helping to treat the infection associated with cat scratch disease.
What is already known about the treatment
Gentamicin
Gentamicin is administered through an intra-nodal injection, specifically targeting lymph nodes. It is currently being studied in clinical trials for its effectiveness in treating suppurative cat scratch disease's lymphadenitis, a condition caused by Bartonellosis. The medication works by inhibiting bacterial protein synthesis, which helps to eliminate the infection. Gentamicin is classified as an aminoglycoside antibiotic, known for its ability to combat a wide range of bacterial infections.
Azithromycin
Azithromycin is taken orally and is commonly used to treat various bacterial infections. In the context of the clinical trial, it is being used as a standard treatment for suppurative cat scratch disease's lymphadenitis. Azithromycin functions by interfering with bacterial protein synthesis, thereby stopping the growth of bacteria. It belongs to the macrolide class of antibiotics, which are known for their broad-spectrum antibacterial activity.
Investigated diseases
Bartonellosis – Bartonellosis is an infectious disease caused by bacteria of the genus Bartonella. It is often transmitted to humans through bites or scratches from infected animals, particularly cats. The disease can lead to symptoms such as fever, fatigue, and swollen lymph nodes, which may become painful and suppurative. In some cases, the lymph nodes may develop into abscesses that require medical intervention. The condition can progress with persistent symptoms if not addressed, but it typically remains localized to the lymph nodes. Bartonellosis is more commonly known as Cat Scratch Disease when associated with cats.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512037-32-00Protocol code15 7834 08Estimated enrolment100 patientsSponsorCentre Hospitalier Universitaire De Toulouse
sourced from the EU Clinical Trials Register and site verification
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