Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Factores de patogenicidad de Staphylococcus Pettenkoferi en heridas del pie y osteítis en pacientes diabéticos (PETTENK-OS)

22 de septiembre de 2026 actualizado por: Centre Hospitalier Universitaire de Nīmes

Evaluación de factores de patogenicidad de Staphylococcus Pettenkoferi en heridas del pie y osteítis en pacientes diabéticos. El estudio PETTENK-OS

Gram-positive cocci, particularly Staphylococcus aureus and coagulase-negative staphylococci (SCoN), are the bacteria most frequently isolated from diabetic foot ulcers. Although studies have been carried out on the role of S. aureus in the unfavorable evolution of these wounds, no studies have focused on the role of SCoN. Of the fifty or so SCoN species, not all have the same virulence potential. The role of Staphylococcus pettenkoferi is unknown, yet this bacterium is the 7th most frequently identified in diabetic foot ulcers, suggesting that it may also be involved in the pathophysiology of these infections. At Nîmes University Hospital, this bacterium is mainly identified in samples from diabetic foot ulcers or osteitis in our laboratory and 80% of the bacteria present are in biofilms.It is essential to understand the mechanisms governing these bacterial interactions and establish the true pathogenic potential of these bacteria. Recently, the Nîmes team showed that a strain of S. pettenkoferi (SP165) isolated from foot osteitis in a diabetic patient had real virulence potential. SP165 could not only produce biofilm, but could also survive in human blood, human keratinocytes and murine and human macrophages. It also caused significant embryonic mortality in a zebrafish model. A second study of 29 isolates from Nîmes University Hospital subsequently demonstrated that there were two predominant clones with different virulences. Three biofilm production profiles (rapidly and highly biofilm-producing, slowly biofilm-producing and non-biofilm-producing) and two zebrafish profiles (highly and moderately lethal) were reported by phenotypic and genomic analyses on this panel of strains. Genes for resistance, virulence and biofilm production were also found on their genomes.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Gram-positive cocci, in particular Staphylococcus aureus and coagulase-negative staphylococci (SCoN), are the bacteria most frequently isolated from diabetic foot ulcers. While studies have been carried out on the role of S. aureus in the unfavorable evolution of these wounds, no study has focused on the role of SCoN. Of the fifty or so SCoN species, not all have the same virulence potential. The role of Staphylococcus pettenkoferi is not known. Yet this bacterium is the 7th most frequently identified in diabetic foot ulcers, suggesting that it may also be involved in the pathophysiology of these infections. In the work of Loetsche et al. a study of the microbiome of 349 diabetic foot ulcer samples by targeted 16S rDNA sequencing showed that the genus Staphylococcus was the most abundant, with a relative abundance of 22.8%, including 13.3% S. aureus and 5.3% S. pettenkoferi.

At Nîmes University Hospital, this bacterium is mainly identified in samples from diabetic foot ulcers or osteitis in our laboratory (89 isolations of S. pettenkoferi from diabetic foot ulcer samples out of 167 isolations made of this bacterium between 2018 and 2022).The difficulty of managing chronic wounds also lies in the fact that almost 80% of the bacteria present are in biofilms. It has also been established that the environment in which bacteria are found, and in particular the interactions they establish between themselves, play a significant role in delayed wound healing. It is therefore essential to understand the mechanisms governing these bacterial interactions and to establish the true pathogenic potential of these bacteria.

Recently, our team demonstrated that a strain of S. pettenkoferi (SP165) isolated from foot osteitis in a diabetic patient had real virulence potential. As well as being able to produce biofilm, SP165 was able to survive in human blood, human keratinocytes and murine and human macrophages. It also demonstrated its virulence by causing significant embryonic mortality in the zebrafish model.

A second study of 29 isolates from Nîmes University Hospital subsequently demonstrated the existence of two predominant clones with different virulences.

Three biofilm production profiles (rapidly and highly biofilm-producing, slowly biofilm-producing and non-biofilm-producing) and two zebrafish virulence profiles (highly and moderately lethal) were reported by phenotypic and genomic analyses on this panel of strains. Genes for resistance, virulence and biofilm production were also found on their genomes.

Tipo de estudio

De observación

Inscripción (Actual)

230

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Francia
    • Gard
      • Nîmes, Gard, Francia, 30029
        • Nîmes University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The collection of strains at the Nîmes University Hospital site from 9 European laboratories collected between 2015 and 2023 for a total of 108 months was carried out between November 2021 and August 2023.

Descripción

Inclusion Criteria:

  • Not applicable for this research on a ready-constituted collection of strains of Staphylococcus pettenkoferi

Exclusion Criteria:

  • Not applicable for this research on a ready-constituted collection of strains of Staphylococcus pettenkoferi

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: OTHER

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Genetic diversity of Staphyloccocus pettenkoferi strains isolated from osteitis and non-diabetic wounds, blood cultures and nasal carriage.
Periodo de tiempo: Day 0 to 3 months

Number of clades estimated via typing by complete sequencing of the bacterial genomes of all S. pettenkoferi strains and analysis of phylogenetic distances (whole genome and core genome single nucleotide polymorphisms).
Day 0 to 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Genetic diversity of Staphyloccocus pettenkoferi strains isolated from osteitis and non-diabetic wounds, blood cultures and nasal carriage.
Periodo de tiempo: 3 - 6 months

Number of clades estimated via typing by complete sequencing of the bacterial genomes of all Staphylococcus pettenkoferi strains and analysis of phylogenetic distances.
3 - 6 months
Resistome in the strain population according to sample origin:osteitis
Periodo de tiempo: 3 - 6 months

The presence of antibiotic resistance genes (resistome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Resistome in the strain population according to sample origin: non-diabetic wounds
Periodo de tiempo: 3 - 6 months

The presence of antibiotic resistance genes (resistome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Resistome in the strain population according to sample origin: diabetic wounds
Periodo de tiempo: 3 - 6 months

The presence of antibiotic resistance genes (resistome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Resistome in the strain population according to sample origin: blood cultures
Periodo de tiempo: 3 - 6 months

The presence of antibiotic resistance genes (resistome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Resistome in the strain population according to sample origin: nasal carriage
Periodo de tiempo: 3 - 6 months

The presence of antibiotic resistance genes (resistome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Virulome in the strain population according to sample origin: osteitis
Periodo de tiempo: 3 - 6 months

The presence of virulence genes (virulome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Virulome in the strain population according to sample origin: non-diabetic wounds
Periodo de tiempo: 3 - 6 months

The presence of virulence genes (virulome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Virulome in the strain population according to sample origin: diabetic wounds
Periodo de tiempo: 3 - 6 months

The presence of virulence genes (virulome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Virulome in the strain population according to sample origin: blood cultures
Periodo de tiempo: 3 - 6 months

The presence of virulence genes (virulome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Virulome in the strain population according to sample origin: nasal carriage
Periodo de tiempo: 3 - 6 months

The presence of virulence genes (virulome) will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Plasmids inthe strain population and according to sample origin: osteitis
Periodo de tiempo: 3 - 6 months

The presence of plasmids will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Plasmids inthe strain population and according to sample origin: non-diabetic wounds
Periodo de tiempo: 3 - 6 months

The presence of plasmids will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Plasmids inthe strain population and according to sample origin: diabetic wounds
Periodo de tiempo: 3 - 6 months

The presence of plasmids will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Plasmids inthe strain population and according to sample origin: blood cultures
Periodo de tiempo: 3 - 6 months

The presence of plasmids will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Plasmids inthe strain population and according to sample origin: nasal carriage
Periodo de tiempo: 3 - 6 months

The presence of plasmids will be identified by bioinformatics analysis of sequenced bacterial genomes.
3 - 6 months
Phenotypic resistance profiles in the population in a subsample of 85 strains
Periodo de tiempo: 6 - 14 months

The minimum inhibitory concentration for a series of antibiotics will be recorded (antibiograms of isolates).These antibiograms will be established on newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin.
6 - 14 months
Phenotypic resistance profiles in the population and according to sample origin: osteitis
Periodo de tiempo: 6 - 14 months

Minimum inhibitory concentration for a series of antibiotics (antibiograms of isolates). These antibiograms will be established on newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin.
6 - 14 months
Phenotypic resistance profiles in the population and according to sample origin: non-diabetic wounds
Periodo de tiempo: 6 - 14 months

Minimum inhibitory concentration for a series of antibiotics (antibiograms of isolates). These antibiograms will be established on newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin.
6 - 14 months
Phenotypic resistance profiles in the population and according to sample origin: diabetic wounds
Periodo de tiempo: 6 - 14 months

Minimum inhibitory concentration for a series of antibiotics (antibiograms of isolates). These antibiograms will be established on newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin.
6 - 14 months
Phenotypic resistance profiles in the population and according to sample origin: blood cultures
Periodo de tiempo: 6 - 14 months

Minimum inhibitory concentration for a series of antibiotics (antibiograms of isolates). These antibiograms will be established on newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin.
6 - 14 months
Phenotypic resistance profiles in the population and according to sample origin: nasal carriage
Periodo de tiempo: 6 - 14 months

Minimum inhibitory concentration for a series of antibiotics (antibiograms of isolates). These antibiograms will be established on newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin.
6 - 14 months
Amount of biofilm formation in the absence and presence of antibiotics in a selection (85 sub-samples) of S. pettenkoferi strains according to sample origine: osteitis
Periodo de tiempo: 6 - 14 months

Biofilm formation index in the presence/absence of a series of antibiotics (antibiograms of isolates). These antibiotics will be newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin. Results recorded on a scale ranging from 0 = biofilm and 12 = no biofilm
6 - 14 months
Amount of biofilm formation in the absence and presence of antibiotics in a selection (85 sub-samples) of S. pettenkoferi strains according to sample origine: non-diabetic wounds
Periodo de tiempo: 6 - 14 months

Biofilm formation index in the presence/absence of a series of antibiotics (antibiograms of isolates). These antibiotics will be newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin. Results recorded on a scale ranging from 0 = biofilm and 12 = no biofilm
6 - 14 months
Amount of biofilm formation in the absence and presence of antibiotics in a selection (85 sub-samples) of S. pettenkoferi strains according to sample origine: diabetic wounds
Periodo de tiempo: 6 - 14 months

Biofilm formation index in the presence/absence of a series of antibiotics (antibiograms of isolates). These antibiotics will be newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin. Results recorded on a scale ranging from 0 = biofilm and 12 = no biofilm
6 - 14 months
Amount of biofilm formation in the absence and presence of antibiotics in a selection (85 sub-samples) of S. pettenkoferi strains according to sample origine: blood cultures
Periodo de tiempo: 6 - 14 months

Biofilm formation index in the presence/absence of a series of antibiotics (antibiograms of isolates). These antibiotics will be newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin. Results recorded on a scale ranging from 0 = biofilm and 12 = no biofilm
6 - 14 months
Amount of biofilm formation in the absence and presence of antibiotics in a selection (85 sub-samples) of S. pettenkoferi strains according to sample origine: nasal carriage
Periodo de tiempo: 6 - 14 months

Biofilm formation index in the presence/absence of a series of antibiotics (antibiograms of isolates). These antibiotics will be newly-marketed or current molecules such as Ceftarolin, Ceftobiprol, Dalbavancin, Delafloxacin, Tedizolid and Oritavancin. Results recorded on a scale ranging from 0 = biofilm and 12 = no biofilm
6 - 14 months
Bacterial growth rate according to sample origin in a sub-sample of 20 strains: osteitis
Periodo de tiempo: 6 - 14 months

Bacterial growth curve by measuring absorbance on bacterial culture over time.
6 - 14 months
Bacterial growth rate according to sample origin in a sub-sample of 20 strains: non-diabetic wounds
Periodo de tiempo: 6 - 14 months

Bacterial growth curve by measuring absorbance on bacterial culture over time.
6 - 14 months
Bacterial growth rate according to sample origin in a sub-sample of 20 strains: diabetic wounds
Periodo de tiempo: 6 - 14 months

Bacterial growth curve by measuring absorbance on bacterial culture over time.
6 - 14 months
Bacterial growth rate according to sample origin in a sub-sample of 20 strains: blood cultures
Periodo de tiempo: 6 - 14 months

Bacterial growth curve by measuring absorbance on bacterial culture over time.
6 - 14 months
Bacterial growth rate according to sample origin in a sub-sample of 20 strains: nasal carriage
Periodo de tiempo: 6 - 14 months

Bacterial growth curve by measuring absorbance on bacterial culture over time.
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains: osteitis
Periodo de tiempo: 6 - 14 months

The rate of internalisation and release of LDH (a sign of cellular toxicity of the bacterial isolate) in an in vitro osteoblast cell culture model (MC3T3-E1)
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains: intracellular bacterial multiplication of S. pettenkoferi strains from osteitis
Periodo de tiempo: 6 - 14 months

The amount of intracellular bacterial multiplication will be assessed in an in vitro macrophage cell culture model (RAW 264.7).
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains: diabetic wounds
Periodo de tiempo: 6 - 14 months

The rate of internalisation and release of LDH (a sign of cellular toxicity of the bacterial isolate) in an in vitro osteoblast cell culture model (MC3T3-E1)
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains: intracellular bacterial multiplication of S. pettenkoferi strains from diabetic wounds
Periodo de tiempo: 6 - 14 months

The amount of intracellular bacterial multiplication will be assessed in an in vitro macrophage cell culture model (RAW 264.7).
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains: blood cultures
Periodo de tiempo: 6 - 14 months

The rate of internalisation and release of LDH (a sign of cellular toxicity of the bacterial isolate) in an in vitro osteoblast cell culture model (MC3T3-E1)
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains:intracellular bacterial multiplication of S. pettenkoferi strains from blood cultures
Periodo de tiempo: 6 - 14 months

The amount of intracellular bacterial multiplication will be assessed in an in vitro macrophage cell culture model (RAW 264.7).
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains: nasal carriage
Periodo de tiempo: 6 - 14 months

The rate of internalisation and release of LDH (a sign of cellular toxicity of the bacterial isolate) in an in vitro osteoblast cell culture model (MC3T3-E1)
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains:intracellular bacterial multiplication of S. pettenkoferi strains from nasal carriage
Periodo de tiempo: 6 - 14 months

The amount of intracellular bacterial multiplication will be assessed in an in vitro macrophage cell culture model (RAW 264.7).
6 - 14 months
Virulence profiles according to sample origin in a sub-sample of 3 strains: survival time of diabetic zebrafish immersed in S. pettenkoferi strains from osteitis
Periodo de tiempo: Up to 48 hours

Survival curve at 48 hours
Up to 48 hours
Virulence profiles according to sample origin in a sub-sample of 3 strains: survival time of diabetic zebrafish immersed in S. pettenkoferi strains from non-diabetic wounds
Periodo de tiempo: Up to 48 hours

Survival curve at 48 hours
Up to 48 hours
Virulence profiles according to sample origin in a sub-sample of 3 strains: survival time of diabetic zebrafish immersed in S. pettenkoferi strains from diabetic wounds
Periodo de tiempo: Up to 48 hours

Survival curve at 48 hours
Up to 48 hours
Virulence profiles according to sample origin in a sub-sample of 3 strains: survival time of diabetic zebrafish immersed in S. pettenkoferi strains from blood cultures
Periodo de tiempo: Up to 48 hours

Survival curve at 48 hours
Up to 48 hours
Virulence profiles according to sample origin in a sub-sample of 3 strains: survival time of diabetic zebrafish immersed in S. pettenkoferi strains from nasal carriage
Periodo de tiempo: Up to 48 hours

Survival curve at 48 hours
Up to 48 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Centre Hospitalier Universitaire de Nīmes

Colaboradores

Charles University, Czech Republic
University Hospital Muenster
Rennes University Hospital
Nantes University Hospital
Örebro University, Sweden
Universität Tübingen
Staphylococcal National Reference Center, Lyon, France

Investigadores

  • Investigador principal: Chloé MAGNAN, Dr., Nîmes University Hospital, FRANCE

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2024

Finalización primaria (Actual)

31 de diciembre de 2025

Finalización del estudio (Actual)

31 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

9 de noviembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

12 de noviembre de 2024

Publicado por primera vez (Actual)

14 de noviembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NIMAO/2023-2/CM-01

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir