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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gentamicin | Experimental | intra-nodal injection of gentamicin |
|
| Placebo | Placebo Comparator | intra-nodal injection of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gentamicin | Drug | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Informed consent
Suppurated CSD's adenitis:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume MARTIN-BLONDEL, MD, PhD | University Hospital of Toulouse, Infectious & Tropical Diseases department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albi Hospital | Albi | France | ||||
| Amiens-Picardie Hospital |
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|
| placebo | Drug | 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). |
|
|
| 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 |
| 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 | 31059 | France |
| ID | Term |
|---|---|
| D002372 | Cat-Scratch Disease |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D001474 | Bartonella Infections |
| D001476 | Bartonellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008199 | Lymphadenitis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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