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

Phase 3RecruitingNCT03132116

University Hospital, Toulouse100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Cat-Scratch Disease

Interventions

gentamicinDRUG

After inclusion in the study, patient will be randomized. According to randomization, patient will receive an intra-nodal injection of gentamicin . As well, azithromycin will be prescribed for all patients for 5 days. Patients will be followed-up each week until week 4 (Day 28).

placeboDRUG

After inclusion in the study, patient will be randomized. According to randomization, patient will receive an intra-nodal injection of placebo. As well, azithromycin will be prescribed for all patients for 5 days. Patients will be followed-up each week until week 4 (Day 28).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (21)

Albi Hospital

Albi, France

RECRUITING

Amiens-Picardie Hospital

Amiens, France

Outcomes

Primary Outcomes

Frequency at day 28 of CSD's adenitis favorable outcome

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.

Time frame: Day 28

Secondary Outcomes

Reduction of the adenitis

Percentage of volume reduction of the adenitis

Time frame: from Day 0 to Day 28

Evaluation of the pain related to the adenitis

Percentage of reduction of the pain related to the adenitis

Time frame: between Day 0, Day 7 and Day 28

Fistulization of the adenitis

Number of patients with persisting cutaneous fistulization of the adenitis

Time frame: Day 7 and day 28

Surgical action

Number of patients requiring surgical excision or incision of the adenitis

Time frame: Day 28

Protein C reactive

Percentage of decrease of serum Protein C reactive

Time frame: Day 0 and day 7

Antibiotic resistance

Genotypic profile of resistance to macrolides and aminoglycosides

Time frame: Day 28

Safety of treatment

Incidence of Treatment-Emergent Events linked to the study treatment

Central Contacts

Guillaume MARTIN-BLONDEL, MD, PhD

CONTACT

+33 (0) 5 61 77 96 99 martin-blondel.g@chu-toulouse.fr

Alexa DEBARD, MD

CONTACT

+33 (0) 5 61 77 95 86 debard.a@chu-toulouse.fr

Data from ClinicalTrials.gov

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