Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis
- Registration Number
- NCT03132116
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
To compare effect of intra-nodal injection of gentamicin versus placebo on the outcome at 28 days of suppurated cat scratch disease's (CSD) lymphadenitis treated by oral azithromycin.
- Detailed Description
Double blind controlled study versus placebo. Patients with suppurated CSD's lymphadenitis will receive immediately after the pus aspiration (performed for a diagnostic purpose) an intra-nodal injection of gentamicin or of placebo (NaCl 0,9%) and be treated with oral azithromycin for 5 days.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo intra-nodal injection of placebo Gentamicin gentamicin intra-nodal injection of gentamicin
- Primary Outcome Measures
Name Time Method Frequency at day 28 of CSD's adenitis favorable outcome Day 28 Adenitis favorable outcome characterized as : Reduction of the volume of the adenitis, Without requirement of supplementary needle aspirations after day 7's visit, And without requirement of a surgical excision or incision of the adenitis.
- Secondary Outcome Measures
Name Time Method Reduction of the adenitis from Day 0 to Day 28 Percentage of volume reduction of the adenitis
Surgical action Day 28 Number of patients requiring surgical excision or incision of the adenitis
Safety of treatment Day 7 and day 28 Incidence of Treatment-Emergent Events linked to the study treatment
Fistulization of the adenitis Day 7 and day 28 Number of patients with persisting cutaneous fistulization of the adenitis
Protein C reactive Day 0 and day 7 Percentage of decrease of serum Protein C reactive
Evaluation of the pain related to the adenitis between Day 0, Day 7 and Day 28 Percentage of reduction of the pain related to the adenitis
Antibiotic resistance Day 28 Genotypic profile of resistance to macrolides and aminoglycosides
Trial Locations
- Locations (21)
Amiens-Picardie Hospital
🇫🇷Amiens, France
Cahors Hospital
🇫🇷Cahors, France
Nîmes University Hospital
🇫🇷Nîmes, France
Rennes Hospital
🇫🇷Rennes, France
Rodez Hospital
🇫🇷Rodez, France
Limoges University Hospital
🇫🇷Limoges, France
Bordeaux University Hospital
🇫🇷Bordeaux, France
Montauban Hospital
🇫🇷Montauban, France
Pau Hospital
🇫🇷Pau, France
Perpignan Hospital
🇫🇷Perpignan, France
Saint-Nazaire Hospital
🇫🇷Saint-Nazaire, France
Hospices Civils Lyon
🇫🇷Lyon, France
Vendée Hospital
🇫🇷La Roche-sur-Yon, France
Montpellier University Hospital
🇫🇷Montpellier, France
Tarbes Hospital
🇫🇷Tarbes, France
Albi Hospital
🇫🇷Albi, France
Angers Hospital
🇫🇷Angers, France
Auch Hospital
🇫🇷Auch, France
Castres Hospital
🇫🇷Castres, France
Saint-Brieuc Hospital
🇫🇷Saint-Brieuc, France
Microbiology Laboratory
🇫🇷Toulouse, France