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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02565940
• Collaborator: (none)
• Enrollment: 150
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Infection	Other: biopsy

Detailed 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

Study Design

• Study Type: Observational
• Observational Model: Case-Only
• Time Perspective: Prospective
• Study Start Date: Dec 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
diabetic patient with foot infection	Other: biopsy

Outcome Measures

Primary Outcome Measures

1. dermal sample [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille	Paca	France	13354

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: desalbres urielle, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT02565940
• Other Study ID Numbers: 2014-35
• First Posted: Oct 1, 2015
• Last Update Posted: Oct 1, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Infections; Diabetic Foot

Study Results

No Results Posted as of Oct 1, 2015