Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphad… (NCT03132116) | Clinical Trial Compass
CompletedPhase 3
Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis
France75 participantsStarted 2017-05-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
What they're measuring
1
Frequency at day 28 of CSD's adenitis favorable outcome