Gentamicin injection for treating lymphadenitis from cat scratch disease
Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study
PHASE3 · University Hospital, Toulouse · NCT03132116
This study is testing if an injection of gentamicin can help people with swollen lymph nodes from cat scratch disease feel better compared to a placebo treatment.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 21 sites (Albi and 20 other locations) |
| Trial ID | NCT03132116 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effects of intra-nodal injection of gentamicin against a placebo in patients suffering from suppurated lymphadenitis caused by cat scratch disease. After pus aspiration for diagnostic purposes, participants will receive either gentamicin or a saline placebo, alongside a 5-day course of oral azithromycin. The study is double-blind and controlled, aiming to assess outcomes at 28 days post-treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals with confirmed suppurated cat scratch disease lymphadenitis who meet the inclusion criteria.
Not a fit: Patients with non-suppurated lymphadenitis or those with other conditions unrelated to cat scratch disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients suffering from severe lymphadenitis due to cat scratch disease.
How similar studies have performed: While this approach is novel in the context of cat scratch disease, similar interventions using intra-nodal injections have shown promise in other infectious diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent * Suppurated CSD's adenitis: * Suppurated form of adenitis confirmed by echography * Serology positive for Immunoglobulin G and/or Immunoglobulin M against B. henselae Exclusion Criteria: * Suppurated adenitis non related to CSD * Non-suppurated CSD's adenitis * Suppurated CSD's adenitis already fistulized * Suspected visceral B. henselae infection (neurologic or ophthalmic symptoms, hepato-splenic or valvular involvement confirmed by echography) * Immunodepression (except diabetes) * Pregnancy * Contraindication to pus aspiration from lymphadenitis (history of bleeding or patient taking curative anticoagulation therapy or platelet count \< 50.000/mm3) * Contraindication to azithromycin (history of QT interval prolongation, history of liver toxicity of hypersensitivity to macrolides or treatment with ergotamine, dihydroergotamine, bepridil, cisapride, pimozide, mizolastine or colchicine) or to aminoglycosides (myasthenia, history of hypersensitivity to aminoglycosides).
Where this trial is running
Albi and 20 other locations
- Albi Hospital — Albi, France (RECRUITING)
- Amiens-Picardie Hospital — Amiens, France (RECRUITING)
- Angers Hospital — Angers, France (RECRUITING)
- Auch Hospital — Auch, France (RECRUITING)
- Bordeaux University Hospital — Bordeaux, France (RECRUITING)
- Cahors Hospital — Cahors, France (RECRUITING)
- Castres Hospital — Castres, France (RECRUITING)
- Vendée Hospital — La Roche-sur-Yon, France (RECRUITING)
- Limoges University Hospital — Limoges, France (RECRUITING)
- Hospices Civils Lyon — Lyon, France (RECRUITING)
- Montauban Hospital — Montauban, France (RECRUITING)
- Montpellier University Hospital — Montpellier, France (RECRUITING)
- Nîmes University Hospital — Nîmes, France (RECRUITING)
- Pau Hospital — Pau, France (RECRUITING)
- Perpignan Hospital — Perpignan, France (RECRUITING)
- Rennes Hospital — Rennes, France (RECRUITING)
- Rodez Hospital — Rodez, France (RECRUITING)
- Saint-Brieuc Hospital — Saint-Brieuc, France (RECRUITING)
- Saint-Nazaire Hospital — Saint-Nazaire, France (RECRUITING)
- Tarbes Hospital — Tarbes, France (RECRUITING)
- Microbiology Laboratory — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Guillaume MARTIN-BLONDEL, MD, PhD — University Hospital of Toulouse, Infectious & Tropical Diseases department
- Study coordinator: Guillaume MARTIN-BLONDEL, MD, PhD
- Email: martin-blondel.g@chu-toulouse.fr
- Phone: +33 (0) 5 61 77 96 99
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cat-Scratch Disease, Cat Scratch Disease's lymphadenitis, Infectious Diseases