Interest of Intra-nodal injection of gentamicin for the treatment of suppurated cat scratch disease's lymphadenitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

31 May 2017 → 21 Aug 2025

Decision date (initial)

2024-09-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512037-32-00

EudraCT number

2016-001576-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare the effect of an intra-nodal injection of gentamicin versus placebo on the outcome at 28 days in patients with suppurative cat scratch disease's lymphadenitis treated with oral azithromycin.

Secondary objectives 3

1. Compare the effect of an intra-nodal injection of gentamicin versus placebo on: The ultrasound evolution of the volume of the lymphadenopathy between D0 and D28, the evolution of pain measured by visual analog scale, the duration of cutaneous fistulization of adenitis, the need for additional evacuation punctures, the need for an excision or surgical incision, changes in serum C-reactive protein levels between D0 and D7
2. Genotypic profile of resistance of B. henselae to macrolides and aminoglycosides
3. Safety of intra-nodal injection of gentamicin or placebo

Conditions and MedDRA coding

Bartonellosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adults ≥18 years old
2. Informed consent
3. Suppurated cat-scratch disease’s adenitis: Suppurated form of adenitis confirmed by echography and serology positive for IgG and/or IgM against B. henselae
4. Affiliation to the French Social Security System

Exclusion criteria 11

1. Suppurated adenitis non related to cat scratch disease
2. Non-suppurated cat scratch disease’s adenitis
3. Suppurated cat scratch disease’s adenitis already fistulized
4. Suspected visceral B. henselae infection (neurologic or ophthalmic symptoms, hepato-splenic or valvular involvement confirmed by echography)
5. Immunodepression (except diabetes)
6. Pregnancy
7. Contraindication to pus aspiration from lymphadenitis (history of bleeding or patient taking curative anticoagulation therapy or platelet count < 50.000/mm3)
8. Contraindication to azithromycin (history of QT interval prolongation, history of liver toxicity of hypersensitivity to macrolides or treatment with ergotamine, dihyroergotamine, bepridil, cisapride, pimozide, mizolastine or colchicine) or to aminoglycosids (myasthenia, history of hypersensitivity to aminoglycosides)
9. Patient with a contraindication to aminoglycosides (myasthenia gravis, history of hypersensitivity to aminoglycosides)
10. Patient taking a prohibited study treatment
11. Legal protection regime for adults

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Frequency at day 28 of CSD’s adenitis favorable outcome characterized as: Reduction of the volume of the adenitis evaluated by echography of ≥ 80% compared to day 0, Without requirement of supplementary needle aspirations after day 7’s visit, And without requirement of a surgical excision or incision of the adenitis.

Secondary endpoints 8

1. Percentage of volume reduction of the adenitis, evaluated by ultrasound between day 0 and day 28
2. Percentage of reduction of the pain related to the adenitis evaluated by analogic visual scale between day 0, day 7, and day 28
3. Number of patients with persisting cutaneous fistulization of the adenitis at day 7, and day 28
4. Number of patients requiring supplementary needle pus evacuation between day 14 and day 28
5. Number of patients requiring surgical excision or incision of the adenitis
6. Percentage of decrease of serum Protein C reactive level between day 0 and day 7
7. Genotypic profile of resistance to macrolides and aminoglycosides
8. Safety of the intra-nodal injection of gentamicin

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

2 Rue Viguerie

City

Toulouse

Postcode

31300

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

principal investigator

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

clinical research project manager

Locations

1 EU/EEA country · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications