Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis
NCT ID: NCT03132116
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2017-05-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Gentamicin
intra-nodal injection of gentamicin
gentamicin
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).
Placebo
intra-nodal injection of placebo
placebo
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).
Interventions
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gentamicin
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).
placebo
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Guillaume MARTIN-BLONDEL, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse, Infectious & Tropical Diseases department
Locations
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Albi Hospital
Albi, , France
Amiens-Picardie Hospital
Amiens, , France
Angers Hospital
Angers, , France
Auch Hospital
Auch, , France
Bordeaux University Hospital
Bordeaux, , France
Cahors Hospital
Cahors, , France
Castres Hospital
Castres, , France
Vendée Hospital
La Roche-sur-Yon, , France
Limoges University Hospital
Limoges, , France
Hospices Civils Lyon
Lyon, , France
Montauban Hospital
Montauban, , France
Montpellier University Hospital
Montpellier, , France
Nîmes University Hospital
Nîmes, , France
Pau Hospital
Pau, , France
Perpignan Hospital
Perpignan, , France
Rennes Hospital
Rennes, , France
Rodez Hospital
Rodez, , France
Saint-Brieuc Hospital
Saint-Brieuc, , France
Saint-Nazaire Hospital
Saint-Nazaire, , France
Tarbes Hospital
Tarbes, , France
Microbiology Laboratory
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Marie-Anne LAFFONT, MD
Role: primary
Jean-Luc SCHMIT, MD
Role: primary
Vincent DUBEE, MD
Role: primary
Sophie ARISTA, MD
Role: primary
Michel DUPON, MD
Role: primary
Stéphane SIRE, MD
Role: primary
Florence-Sarah KHATIBI, MD
Role: primary
Thomas GUIMARD, MD
Role: primary
Pierre WEINBRECK, MD
Role: primary
Florence ADER, MD
Role: primary
Marc DELAVAISSIERE, MD
Role: primary
David MORQUIN, MD
Role: primary
Catherine LECHICHE, MD
Role: primary
Valérie GABORIEAU, MD
Role: primary
Léa COLOMBAIN, MD
Role: primary
Matthieu REVEST, MD
Role: primary
Bruno GUERIN, MD
Role: primary
Rodolphe BUZELE, MD
Role: primary
Julia BROCHARD, MD
Role: primary
Florian BUSATO, MD
Role: primary
Guillaume MARTIN-BLONDEL, MD
Role: primary
Other Identifiers
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15 7834 08
Identifier Type: -
Identifier Source: org_study_id
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