Cat-Scratch Disease
Conditions
Keywords
Cat Scratch Disease's lymphadenitis, Infectious Diseases
Brief summary
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
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.
Interventions
DRUGgentamicin
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).
DRUGplacebo
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).
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency at day 28 of CSD's adenitis favorable outcome | Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the adenitis | from Day 0 to Day 28 | Percentage of volume reduction of the adenitis |
| Evaluation of the pain related to the adenitis | between Day 0, Day 7 and Day 28 | Percentage of reduction of the pain related to the adenitis |
| Fistulization of the adenitis | Day 7 and day 28 | Number of patients with persisting cutaneous fistulization of the adenitis |
| Surgical action | Day 28 | Number of patients requiring surgical excision or incision of the adenitis |
| Protein C reactive | Day 0 and day 7 | Percentage of decrease of serum Protein C reactive |
| Antibiotic resistance | Day 28 | Genotypic profile of resistance to macrolides and aminoglycosides |
| Safety of treatment | Day 7 and day 28 | Incidence of Treatment-Emergent Events linked to the study treatment |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGuillaume MARTIN-BLONDEL, MD, PhD
University Hospital of Toulouse, Infectious & Tropical Diseases department
Outcome results
None listed