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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study

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 Summary: 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.
Sponsor: University Hospital, Toulouse

Current Primary Outcome: Frequency at day 28 of CSD's adenitis favorable outcome [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction of the adenitis [ Time Frame: from Day 0 to Day 28 ]
    Percentage of volume reduction of the adenitis
  • Evaluation of the pain related to the adenitis [ Time Frame: between Day 0, Day 7 and Day 28 ]
    Percentage of reduction of the pain related to the adenitis
  • Fistulization of the adenitis [ Time Frame: Day 7 and day 28 ]
    Number of patients with persisting cutaneous fistulization of the adenitis
  • Surgical action [ Time Frame: Day 28 ]
    Number of patients requiring surgical excision or incision of the adenitis
  • Protein C reactive [ Time Frame: Day 0 and day 7 ]
    Percentage of decrease of serum Protein C reactive
  • Antibiotic resistance [ Time Frame: Day 28 ]
    Genotypic profile of resistance to macrolides and aminoglycosides
  • Safety of treatment [ Time Frame: Day 7 and day 28 ]
    Incidence of Treatment-Emergent Events linked to the study treatment


Original Secondary Outcome:

  • Reduction of the adenitis [ Time Frame: from Day 0 to Day 28 ]
    Percentage of volume reduction of the adenitis
  • Evaluation of the pain related to the adenitis [ Time Frame: between Day 0, Day 7 and Day 28 ]
    Percentage of reduction of the pain related to the adenitis
  • Fistulization of the adenitis [ Time Frame: Day 7 and day 28 ]
    Number of patients with persisting cutaneous fistulization of the adenitis
  • Surgical action [ Time Frame: Day 28 ]
    Number of patients requiring surgical excision or incision of the adenitis
  • Protein C reactive [ Time Frame: Day 0 and day 7 ]
    Percentage of decrease of serum Protein C reactive
  • Antibiotic resistance [ Time Frame: Day 28 ]
    Genotypic profile of resistance to macrolides and aminoglycosides
  • Safety of treatment [ Time Frame: Day 7 and day 28 ]
    Safety of the intra-nodal injection of gentamicin


Information By: University Hospital, Toulouse

Dates:
Date Received: March 5, 2017
Date Started: June 2017
Date Completion: October 2020
Last Updated: April 27, 2017
Last Verified: April 2017