Clinical trial NCT03132116: Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis
Official title: Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cat-Scratch Disease
Keywords: Cat Scratch Disease's lymphadenitis
Infectious Diseases
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 injection of gentamicin or of placebo (NaCl 0,9%) and be treated with oral azithromycin for 5 days.

Eligibility criteria: 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).

Primary outcomes:
measure: Frequency at day 28 of CSD's adenitis favorable outcome
timeFrame: Day 28
Secondary outcomes:
measure: Reduction of the adenitis
timeFrame: from Day 0 to Day 28
measure: Evaluation of the pain related to the adenitis
timeFrame: between Day 0, Day 7 and Day 28
measure: Fistulization of the adenitis
timeFrame: Day 7 and day 28
measure: Surgical action
timeFrame: Day 28
measure: Protein C reactive
timeFrame: Day 0 and day 7
measure: Antibiotic resistance
timeFrame: Day 28
measure: Safety of treatment
timeFrame: Day 7 and day 28
Other outcomes:
Locations:
city: Albi
country: France
facility: Albi Hospital
city: Amiens
country: France
facility: Amiens-Picardie Hospital
city: Angers
country: France
facility: Angers Hospital
city: Auch
country: France
facility: Auch Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Cahors
country: France
facility: Cahors Hospital
city: Castres
country: France
facility: Castres Hospital
city: La Roche-sur-Yon
country: France
facility: Vendée Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Lyon
country: France
facility: Hospices Civils Lyon
city: Montauban
country: France
facility: Montauban Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nîmes
country: France
facility: Nîmes University Hospital
city: Pau
country: France
facility: Pau Hospital
city: Perpignan
country: France
facility: Perpignan Hospital
city: Rennes
country: France
facility: Rennes Hospital
city: Rodez
country: France
facility: Rodez Hospital
city: Saint-Brieuc
country: France
facility: Saint-Brieuc Hospital
city: Saint-Nazaire
country: France
facility: Saint-Nazaire Hospital
city: Tarbes
country: France
facility: Tarbes Hospital
city: Toulouse
country: France
facility: Microbiology Laboratory
Study officials:
affiliation: University Hospital of Toulouse, Infectious & Tropical Diseases department
name: Guillaume MARTIN-BLONDEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: