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

Toulouse University Hospital

Status and phase: Enrolling; Phase 3

Conditions: Cat-Scratch Disease

Treatments: Drug: placebo; Drug: gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT03132116

15 7834 08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Gentamicin

Experimental group

Description:

intra-nodal injection of gentamicin

Treatment:

Drug: gentamicin

Placebo

Placebo Comparator group

Description:

intra-nodal injection of placebo

Treatment:

Drug: placebo