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

Last updated: August 26, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

3

Condition

Soft Tissue Infections

Treatment

placebo

gentamicin

Clinical Study ID

NCT03132116
15 7834 08
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 orpatient taking curative anticoagulation therapy or platelet count < 50.000/mm3)

  • Contraindication to azithromycin (history of QT interval prolongation, history ofliver toxicity of hypersensitivity to macrolides or treatment with ergotamine,dihydroergotamine, bepridil, cisapride, pimozide, mizolastine or colchicine) or toaminoglycosides (myasthenia, history of hypersensitivity to aminoglycosides).

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: placebo
Phase: 3
Study Start date:
May 31, 2017
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Albi Hospital

    Albi,
    France

    Active - Recruiting

  • Amiens-Picardie Hospital

    Amiens,
    France

    Active - Recruiting

  • Angers Hospital

    Angers,
    France

    Active - Recruiting

  • Auch Hospital

    Auch,
    France

    Active - Recruiting

  • Bordeaux University Hospital

    Bordeaux,
    France

    Active - Recruiting

  • Cahors Hospital

    Cahors,
    France

    Active - Recruiting

  • Castres Hospital

    Castres,
    France

    Active - Recruiting

  • Vendée Hospital

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • Limoges University Hospital

    Limoges,
    France

    Active - Recruiting

  • Hospices Civils Lyon

    Lyon,
    France

    Active - Recruiting

  • Montauban Hospital

    Montauban,
    France

    Active - Recruiting

  • Montpellier University Hospital

    Montpellier,
    France

    Active - Recruiting

  • Nîmes University Hospital

    Nîmes,
    France

    Active - Recruiting

  • Pau Hospital

    Pau,
    France

    Active - Recruiting

  • Perpignan Hospital

    Perpignan,
    France

    Active - Recruiting

  • Rennes Hospital

    Rennes,
    France

    Active - Recruiting

  • Rodez Hospital

    Rodez,
    France

    Active - Recruiting

  • Saint-Brieuc Hospital

    Saint-Brieuc,
    France

    Active - Recruiting

  • Saint-Nazaire Hospital

    Saint-Nazaire,
    France

    Active - Recruiting

  • Tarbes Hospital

    Tarbes,
    France

    Active - Recruiting

  • Microbiology Laboratory

    Toulouse, 31059
    France

    Active - Recruiting

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