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

NCT03132116 | Completed Phase 3

• 1 other identifier: 15 7834 08
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 21

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.

Conditions

Cat-Scratch Disease

Keywords

Cat Scratch Disease's lymphadenitis; Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Reduction of the adenitis

  from Day 0 to Day 28

• Evaluation of the pain related to the adenitis

  between Day 0, Day 7 and Day 28

• Fistulization of the adenitis

  Day 7 and day 28

• Surgical action

  Day 28

• Protein C reactive

  Day 0 and day 7

Study Arms (2)

Gentamicin

EXPERIMENTAL

intra-nodal injection of gentamicin

Drug: gentamicin

Placebo

PLACEBO COMPARATOR

intra-nodal injection of placebo

Drug: placebo

Interventions

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).

Gentamicin

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).

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (21)

Albi Hospital

Albi, France

Location

Amiens-Picardie Hospital

Amiens, France

Location

Angers Hospital

Angers, France

Location

Auch Hospital

Auch, France

Location

Bordeaux University Hospital

Bordeaux, France

Location

Cahors Hospital

Cahors, France

Location

Castres Hospital

Castres, France

Location

Vendée Hospital

La Roche-sur-Yon, France

Location

Limoges University Hospital

Limoges, France

Location

Hospices Civils Lyon

Lyon, France

Location

Montauban Hospital

Montauban, France

Location

Montpellier University Hospital

Montpellier, France

Location

Nîmes University Hospital

Nîmes, France

Location

Pau Hospital

Pau, France

Location

Perpignan Hospital

Perpignan, France

Location

Rennes Hospital

Rennes, France

Location

Rodez Hospital

Rodez, France

Location

Saint-Brieuc Hospital

Saint-Brieuc, France

Location

Saint-Nazaire Hospital

Saint-Nazaire, France

Location

Tarbes Hospital

Tarbes, France

Location

Microbiology Laboratory

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Cat-Scratch Disease; Communicable Diseases

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Bartonella Infections; Bartonellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Lymphadenitis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Guillaume MARTIN-BLONDEL, MD, PhD

  University Hospital of Toulouse, Infectious & Tropical Diseases department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: April 27, 2017
• Study Start: May 31, 2017
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)