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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Page 1 of 6 (21 locations)

1

Albi Hospital

Albi, France

2

Amiens-Picardie Hospital

Amiens, France

3

Angers Hospital

Angers, France

4

Auch Hospital

Auch, France

Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis | DecenTrialz