Bartonellosis MedDRA version: 19.0 Level: PT Classification code 10004145 Term: Bartonellosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Gentamicine
Product Name: Gentamicine
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intrale
Sponsors
CHU TOULOUSE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim is to assess the benefit of an intra-nodal injection at 28 days of gentamicin add-on oral azithromycin on the outcome of suppurated cat scratch disease’s lymphadenitis in adults.;Secondary Objective: •To compare the effect of gentamicine intra-nodal injection versus saline injection on : -adenitis volume echographic evolution between day 0 and day 28 -evolution of the pain related to the adenitis evaluated by analogic visual scale between day 0 and day 28 -time with persisting cutaneous fistulization of the adenitis -requirement supplementary needle pus evacuation -requirement surgical excision or incision of the adenitis -serum Protein C reactive level between day 0 and day 7 -genotypic profile of resistance to macrolides and aminoglycosides -safety of the intra-nodal injection of gentamicin;Primary end point(s): Frequency at day 28 of CSD’s adenitis unfavorable outcome, using a combined criterion that includes oa reduction of the volume of the adenitis evaluated by echography of < 80% compared to day 0, o and/or the requirement of supplementary needle aspirations between day 14 and day 28, oand/or the requirement of a surgical excision or incision of the adenitis. ;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of volume reduction of the adenitis, evaluated by ultrasound between day 0 and day 28 - Percentage of reduction of the pain related to the adenitis evaluated by analogic visual scale between day 0, day 7 and day 28 - Percentage of patients with persisting cutaneous fistulization of the adenitis at day 7, day 14, day 21 and day 28 - Percentage of patients requiring supplementary needle pus evacuation between day 14 and day 28 - Percentage of patients requiring surgical excision or incision of the adenitis - Percentage of decrease of serum Protein C reactive level between day 0 and day 7 - Genotypic profile of resistance to macrolides and aminoglycosides - Safety of the intra-nodal injection of gentamicin ;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
France
Contacts
Public ContactCLINICAL RESEARCH ASSISTANT
CHU TOULOUSE
Outcome results
None listed