Assessment of PCR Multiplex Tests as a Tool to Obtain a Quicker Diagnosis of Bacteria Responsible for Foot Osteomyelitis Than Usual Cultures (RAPDIAGOS)
|ClinicalTrials.gov Identifier: NCT03434288|
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : June 5, 2020
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Foot Osteomyelitis||Other: Bone sampling|
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.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Pilot Evaluation of PCR Multiplex Tests for a Rapid Diagnosis of Bone Infections in Diabetic Foot|
|Actual Study Start Date :||February 8, 2018|
|Actual Primary Completion Date :||December 1, 2019|
|Actual Study Completion Date :||December 1, 2019|
Diabetic patients with foot osteomyelitis
Biological and MRI signs of foot osteomyelitis
Other: Bone sampling
Bone biopsy in Diabetic patients with foot osteomyelitis
- Time for identification of bacteria responsible for foot osteomyelitis [ Time Frame: 12-48 hours ]The difference of time between usual cultures and PCR multiplex tests to identify responsible bacteria will be assessed
- Time for identification of sensitivity/resistance to antibiotics of the bacteria responsible for foot osteomyelitis [ Time Frame: 12-96 hours ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434288
|Montpellier, France, 34295|
|Principal Investigator:||Eric RENARD, MD, PhD||University Hospital, Montpellier|