Cat-Scratch DiseasePhase 3BIGGNCT03132116
Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis
A Phase 3 study testing gentamicin in people with Cat-Scratch Disease, run by University Hospital, Toulouse at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cat-Scratch Disease
- What is being tested?
- gentamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 21 sitesFrance
- Study dates
- 31 May 2017to 21 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Albi Hospital
Albi
Amiens-Picardie Hospital
Amiens
Angers Hospital
Angers
Auch Hospital
Auch
Bordeaux University Hospital
Bordeaux
Cahors Hospital
Cahors
Castres Hospital
Castres
Vendée Hospital
La Roche-sur-Yon
Limoges University Hospital
Limoges
Hospices Civils Lyon
Lyon
Montauban Hospital
Montauban
Montpellier University Hospital
Montpellier
Nîmes University Hospital
Nîmes
Pau Hospital
Pau
Perpignan Hospital
Perpignan
Rennes Hospital
Rennes
Rodez Hospital
Rodez
Saint-Brieuc Hospital
Saint-Brieuc
Saint-Nazaire Hospital
Saint-Nazaire
Tarbes Hospital
Tarbes
Microbiology Laboratory
Toulouse, 31059
About this study
Official title: 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.
Read the 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.
- Conditions
- Cat-Scratch Disease
- Being tested
- gentamicin, placebo
- Keywords
- Cat Scratch Disease's lymphadenitis, Infectious Diseases
- Medical subject headings
- Cat-Scratch Disease, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamicinDrug
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).
placeboDrug
Also called NaCl
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).
| Study group | Role | What they receive |
|---|---|---|
| Gentamicin | Experimental | intra-nodal injection of gentamicin Receives: Drug: gentamicin |
| Placebo | Placebo comparator | intra-nodal injection of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (7)
Reduction of the adenitis
Percentage of volume reduction of the adenitis
Measured: from Day 0 to Day 28
Evaluation of the pain related to the adenitis
Percentage of reduction of the pain related to the adenitis
Measured: between Day 0, Day 7 and Day 28
Fistulization of the adenitis
Number of patients with persisting cutaneous fistulization of the adenitis
Measured: Day 7 and day 28
Surgical action
Number of patients requiring surgical excision or incision of the adenitis
Measured: Day 28
Protein C reactive
Percentage of decrease of serum Protein C reactive
Measured: Day 0 and day 7
Antibiotic resistance
Genotypic profile of resistance to macrolides and aminoglycosides
Measured: Day 28
Safety of treatment
Incidence of Treatment-Emergent Events linked to the study treatment
Measured: Day 7 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start31 May 2017
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cat-Scratch DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MARTIN-BLONDEL, MD, PhD, Principal investigator, University Hospital of Toulouse, Infectious & Tropical Diseases department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132116
- Sponsor's protocol ID
- 15 7834 08
- Acronym
- BIGG
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2017
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03132116
- Acronym / sponsor ID
- BIGG / 15 7834 08
- Conditions
- Cat-Scratch Disease
- Keywords
- Cat Scratch Disease's lymphadenitis, Infectious Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentamicin | Experimental | Drug: gentamicinintra-nodal injection of gentamicin |
| Placebo | Placebo comparator | Drug: placebointra-nodal injection of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- Suppurated CSD's adenitis:
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gentamicinAfter 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). | Drug | Gentamicin |
| placeboAlso: NaClAfter 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). | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
Reduction of the adenitis
Time frame: from Day 0 to Day 28
Evaluation of the pain related to the adenitis
Time frame: between Day 0, Day 7 and Day 28
Fistulization of the adenitis
Time frame: Day 7 and day 28
Surgical action
Time frame: Day 28
Protein C reactive
Time frame: Day 0 and day 7
Antibiotic resistance
Time frame: Day 28
Safety of treatment
Time frame: Day 7 and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume MARTIN-BLONDEL, MD, PhD principal investigator
University Hospital of Toulouse, Infectious & Tropical Diseases department
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gentamicin in people with Cat-Scratch Disease, run by University Hospital, Toulouse at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency at day 28 of CSD's adenitis favorable outcome (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.