Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection

Diabetic Foot Infection Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565940
• Other study ID #: 2014-35
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2015
• Last updated: September 30, 2015
• Start date: December 2014

Study information

• Verified date: September 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: levy pierre
• Email: pierre.levy[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.

Description:

Patients will be included by the infectious and tropical diseases and diabetes services the Nîmes Teaching Hospital which have a large active file and proven expertise internationally in this pathology. The usual agents of infection will be searched by standard bacteriological techniques as part of the microbiological documentation of such cases and will be performed by the microbiology laboratory of CHU Nîmes which will freeze the rest of the sample to -80 ° C the will send it to the Marseille Microbiology Federation for realization of metagenomics-culturomics

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients were taken care by the services(departments) of Diabetology or Infectious diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2
• 4 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004], inaugural or récidivante.

Exclusion Criteria:

• The patient participates in another study

• The patient is in period of exclusion determined by a previous study

• The patient is under protection(saving) of justice, under guardianship or under guardianship

• The patient refuses to sign the consent

• It turns out impossible to give about the lit(enlightened) information

• The patient is pregnant, parturiente, or she breast-feeds

• The patients having no wound

• The patients diabetics having a wound chronicles of Rank 1 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004]

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Infection

Intervention

Other:
• biopsy

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dermal sample		36 months	No