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

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

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.

Study Overview

• Status: Completed
• Conditions: Cat-Scratch Disease
• Intervention / Treatment: Drug: gentamicin; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Albi, France
    • Albi Hospital
  • Amiens, France
    • Amiens-Picardie Hospital
  • Angers, France
    • Angers Hospital
  • Auch, France
    • Auch Hospital
  • Bordeaux, France
    • Bordeaux University Hospital
  • Cahors, France
    • Cahors Hospital
  • Castres, France
    • Castres Hospital
  • La Roche-sur-Yon, France
    • Vendée Hospital
  • Limoges, France
    • Limoges University Hospital
  • Lyon, France
    • Hospices civils Lyon
  • Montauban, France
    • Montauban Hospital
  • Montpellier, France
    • Montpellier University Hospital
  • Nîmes, France
    • Nîmes University Hospital
  • Pau, France
    • Pau Hospital
  • Perpignan, France
    • Perpignan Hospital
  • Rennes, France
    • Rennes Hospital
  • Rodez, France
    • Rodez Hospital
  • Saint-Brieuc, France
    • Saint-Brieuc Hospital
  • Saint-Nazaire, France
    • Saint-Nazaire Hospital
  • Tarbes, France
    • Tarbes Hospital
  • Toulouse, France, 31059
    • Microbiology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gentamicin; intra-nodal injection of gentamicin	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 Comparator: Placebo; intra-nodal injection of placebo	Drug: 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).; Other Names: NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Guillaume MARTIN-BLONDEL, MD, PhD, University Hospital of Toulouse, Infectious & Tropical Diseases department

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): August 21, 2025
• Study Completion (Actual): August 21, 2025

Study Registration Dates

• First Submitted: March 5, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Infectious Diseases; Cat Scratch Disease's lymphadenitis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Lymphatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Bartonella Infections; Bartonellaceae Infections; Lymphadenitis; Communicable Diseases; Cat-Scratch Disease; Carbohydrates; Glycosides; Aminoglycosides; Gentamicins
• Other Study ID Numbers: 15 7834 08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No