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Interest of Intra-nodal injection of gentamicin for the treatment of suppurated cat scratch disease's lymphadenitis: a randomized controlled study. "BIGG" : Bartonellosis and intra-nodal injection of gentamicin

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512037-32-00
Acronym
15 7834 08
Enrollment
100
Registered
2024-09-12
Start date
2017-05-31
Completion date
2025-08-21
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bartonellosis

Brief summary

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.

Detailed description

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

Interventions

DRUG9 %
DRUGsolution injectable
DRUGZITHROMAX 250 mg tablett
DRUGfilmdragerad

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026