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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cat-Scratch Disease

Intervention / Treatment
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* Drug: gentamicin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gentamicin<br>intra-nodal injection of gentamicin | Drug: gentamicin<br>* 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).<br>|
| Placebo Comparator: Placebo<br>intra-nodal injection of placebo | Drug: placebo<br>* 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).<br>* Other names: NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 28 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cat Scratch Disease's lymphadenitis, Infectious Diseases