Study on Gentamicin and Azithromycin for Treating Lymph Node Infection in Cat Scratch Disease Patients

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What is this study about?

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.

1 initial assessment

Upon joining the study, eligibility is confirmed through an initial assessment. This includes verifying age (18 years or older), obtaining informed consent, and confirming the presence of suppurated cat-scratch disease’s adenitis through echography and serology tests.

2 treatment initiation

The treatment phase begins with the administration of oral azithromycin. This medication is provided in the form of a film-coated tablet, with a dosage of 250 mg. The frequency and duration of administration are determined by the study protocol.

3 intra-nodal injection

Participants receive an intra-nodal injection of gentamicin or a placebo. Gentamicin is administered as a solution for injection directly into the lymph node affected by the disease.

4 follow-up visits

Follow-up visits are scheduled to monitor the progress of the treatment. These visits include evaluations at day 7 and day 28. The primary goal is to assess the reduction in the volume of the adenitis using echography, aiming for a reduction of at least 80% by day 28.

5 evaluation of outcomes

The study evaluates several outcomes, including the percentage of volume reduction of the adenitis, reduction of pain, and the need for additional procedures such as needle aspirations or surgical interventions. Safety of the intra-nodal injection is also assessed.

6 completion of study

The study concludes with a final assessment of the treatment’s effectiveness and safety. The estimated end date for the trial is December 31, 2025.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier D Albi Albi France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Jean Rougier Cahors France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De Perigueux Perigueux France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier De Pau Pau France
Centre Hospitalier Saint Nazaire St Nazaire France
Centre Hospitalier Tarbes-Lourdes Tarbes France
Centre Hospitalier Intercommunal De Castres Mazamet Castres France
Centre Hospitalier D Auch Auch France
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Cradng Hwqrlduexss Rqojmxwd Ddwzswnolgpbax Angers France
Cphbhr Hgwfjazmbvz Da Mzspktbnp Montauban France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
31.05.2017

Trial locations

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.

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 ID:
2024-512037-32-00
Protocol code:
15 7834 08
Trial Phase:
Therapeutic confirmatory (Phase III)

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