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 ]
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