Assessment of PCR Multiplex Tests as a Tool to Obtain a Quicker Diagnosis of Bacteria Responsible for Foot Osteomyelitis Than Usual Cultures

Study Overview
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Brief Summary
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Bone samples from infected diabetic feet will be collected and tests will be performed for the diagnosis of causative bacteria. Samples will be processed by PCR multiplex tests and usual cultures for identification of causative bacteria and sensitivity to antibiotics. Results obtained by the two methods will be compared in terms of quickness and similarity of germ identification. Usual care strategy will not be modified since results of PCR multiplex tests will not be transmitted to the physicians before the results of usual cultures.

Detailed Description
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This study will investigate the quickness of identification of bacteria causing bone infection in the feet of patients with diabetes from bone samples obtained by biopsies performed in usaual care practice. Bone biopsies will be performed in patients diagnosed for osteomyelitis from clinical, biological and MRI signs. Bone samples will be collected in Ultra-Turrax® tubes in the operating theater before being transferred to the department of bacteriology. Time of registration at the bacteriology lab will be considered as Time 0 (T0). Samples will be processed simultaneously using the usual culture method and by PCR Multiplex tests. The time of identification of causative bacteria for bone infection (time 1, T1) and the time of identification of sensitivity/resistance to antibiotics (time 2, T2) by the two different methods will be recorded. Identified germs and their sensitivity/resistance to antibiotics according to the two methods will be compared. If the results are similar, the time that could be gained for the prescription of specific antibiotics from PCR multiplex tests' results will be computed in comparison to the prescription performed from the results of usual cultures.

Official Title
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Pilot Evaluation of PCR Multiplex Tests for a Rapid Diagnosis of Bone Infections in Diabetic Foot

Conditions
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Diabetes Mellitus, Foot Osteomyelitis

Intervention / Treatment
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* Other: Bone sampling


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Biological and MRI signs of foot osteomyelitis Indication of bone biopsy No antibiotics since 2 weeks Exclusion criteria: Antibiotic therapy Previous cultures for the same infectious event

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients with foot osteomyelitis<br>Biological and MRI signs of foot osteomyelitis | Other: Bone sampling<br>* Bone biopsy in Diabetic patients with foot osteomyelitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for identification of bacteria responsible for foot osteomyelitis | The difference of time between usual cultures and PCR multiplex tests to identify responsible bacteria will be assessed | 12-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for identification of sensitivity/resistance to antibiotics of the bacteria responsible for foot osteomyelitis | The difference of time between usual cultures and PCR multiplex tests to identify sensitivity/resistance to antibiotics of responsible bacteria for foot osteomyelitis will be assessed | 12-96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteomyelitis, Diabetes, Diabetic foot