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

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ClinicalTrials.gov Identifier: NCT03132116
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Cat-Scratch Disease Drug: gentamicin Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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 Name: NaCl




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132116


Contacts
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Contact: Guillaume MARTIN-BLONDEL, MD, PhD +33 (0) 5 61 77 96 99 martin-blondel.g@chu-toulouse.fr
Contact: Alexa DEBARD, MD +33 (0) 5 61 77 95 86 debard.a@chu-toulouse.fr

Locations
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France
Albi Hospital Recruiting
Albi, France
Contact: Marie-Anne LAFFONT, MD         
Amiens-Picardie Hospital Recruiting
Amiens, France
Contact: Jean-Luc SCHMIT, MD         
Angers Hospital Recruiting
Angers, France
Contact: Vincent DUBEE, MD         
Auch Hospital Recruiting
Auch, France
Contact: Sophie ARISTA, MD         
Bordeaux University Hospital Recruiting
Bordeaux, France
Contact: Michel DUPON, MD         
Principal Investigator: Michel DUPON, MD         
Principal Investigator: Estibaliz LAZARO, MD         
Principal Investigator: Fabrice BONNET, MD         
Cahors Hospital Recruiting
Cahors, France
Contact: Stéphane SIRE, MD         
Castres Hospital Recruiting
Castres, France
Contact: Florence-Sarah KHATIBI, MD         
Vendée Hospital Recruiting
La Roche-sur-Yon, France
Contact: Thomas GUIMARD, MD         
Limoges University Hospital Recruiting
Limoges, France
Contact: Pierre WEINBRECK, MD         
Hospices Civils Lyon Recruiting
Lyon, France
Contact: Florence ADER, MD         
Montauban Hospital Recruiting
Montauban, France
Contact: Marc DELAVAISSIERE, MD         
Montpellier University Hospital Recruiting
Montpellier, France
Contact: David MORQUIN, MD         
Nîmes University Hospital Recruiting
Nîmes, France
Contact: Catherine LECHICHE, MD         
Pau Hospital Recruiting
Pau, France
Contact: Valérie GABORIEAU, MD         
Perpignan Hospital Recruiting
Perpignan, France
Contact: Léa COLOMBAIN, MD         
Rennes Hospital Recruiting
Rennes, France
Contact: Matthieu REVEST, MD         
Rodez Hospital Recruiting
Rodez, France
Contact: Bruno GUERIN, MD         
Saint-Brieuc Hospital Recruiting
Saint-Brieuc, France
Contact: Rodolphe BUZELE, MD         
Saint-Nazaire Hospital Recruiting
Saint-Nazaire, France
Contact: Julia BROCHARD, MD         
Tarbes Hospital Recruiting
Tarbes, France
Contact: Florian BUSATO, MD         
Microbiology Laboratory Recruiting
Toulouse, France, 31059
Contact: Guillaume MARTIN-BLONDEL, MD         
Principal Investigator: Guillaume MARTIN-BLONDEL, MD,PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Guillaume MARTIN-BLONDEL, MD, PhD University Hospital of Toulouse, Infectious & Tropical Diseases department

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03132116     History of Changes
Other Study ID Numbers: 15 7834 08
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Cat Scratch Disease's lymphadenitis
Infectious Diseases
Additional relevant MeSH terms:
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Cat-Scratch Disease
Lymphadenitis
Lymphatic Diseases
Bartonella Infections
Bartonellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action