Suppurated cat scratch disease’s and intra-nodal injection of gentamici

Phase 1

• Conditions: Bartonellosis; MedDRA version: 19.0 Level: PT Classification code 10004145 Term: Bartonellosis System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-001576-30-FR
• Lead Sponsor: CHU TOULOUSE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

- Adults > or = 18 years old
- Informed consent
- Suppurated CSD’s adenitis:
•Suppurated form of adenitis confirmed by echography
•Serology positive for IgG and/or IgM against B. henselae

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 well equilibrated diabetes)
- Pregnancy or lactating women
- 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, dihyroergotamine, bepridil, cisapride, pimozide, mizolastine or colchicine) or to aminoglycosids (myasthenia, history of hypersensitivity to aminoglycosides)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified