Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis

Cat-Scratch Disease Clinical Trial

— BIGG  

Official title:

Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132116
• Other study ID #: 15 7834 08
• Status: Recruiting
• Phase: Phase 3
• Start date: May 31, 2017
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Guillaume MARTIN-BLONDEL, MD, PhD
• Phone: +33 (0) 5 61 77 96 99
• Email: martin-blondel.g[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cat-Scratch Disease
• Lymphadenitis

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Reduction of the adenitis	Percentage of volume reduction of the adenitis	from Day 0 to Day 28
Secondary	Evaluation of the pain related to the adenitis	Percentage of reduction of the pain related to the adenitis	between Day 0, Day 7 and Day 28
Secondary	Fistulization of the adenitis	Number of patients with persisting cutaneous fistulization of the adenitis	Day 7 and day 28
Secondary	Surgical action	Number of patients requiring surgical excision or incision of the adenitis	Day 28
Secondary	Protein C reactive	Percentage of decrease of serum Protein C reactive	Day 0 and day 7
Secondary	Antibiotic resistance	Genotypic profile of resistance to macrolides and aminoglycosides	Day 28
Secondary	Safety of treatment	Incidence of Treatment-Emergent Events linked to the study treatment	Day 7 and day 28