Status:
RECRUITING
Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Cat-Scratch Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 injecti...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03132116
Start Date
May 31 2017
End Date
December 1 2025
Last Update
August 27 2024
Active Locations (21)
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1
Albi Hospital
Albi, France
2
Amiens-Picardie Hospital
Amiens, France
3
Angers Hospital
Angers, France
4
Auch Hospital
Auch, France