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NCT Number: NCT03132116

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Albi Hospital, Albi, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

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).

Other names: NaCl

Primary outcomes

  1. Frequency at day 28 of CSD's adenitis favorable outcome

    Time frame: 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 outcomes

  1. Reduction of the adenitis

    Time frame: from Day 0 to Day 28

    Percentage of volume reduction of the adenitis

  2. Evaluation of the pain related to the adenitis

    Time frame: between Day 0, Day 7 and Day 28

    Percentage of reduction of the pain related to the adenitis

  3. Fistulization of the adenitis

    Time frame: Day 7 and day 28

    Number of patients with persisting cutaneous fistulization of the adenitis

  4. Surgical action

    Time frame: Day 28

    Number of patients requiring surgical excision or incision of the adenitis

  5. Protein C reactive

    Time frame: Day 0 and day 7

    Percentage of decrease of serum Protein C reactive

  6. Antibiotic resistance

    Time frame: Day 28

    Genotypic profile of resistance to macrolides and aminoglycosides

  7. Safety of treatment

    Time frame: Day 7 and day 28

    Incidence of Treatment-Emergent Events linked to the study treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: BIGG

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2017
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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