An observational study in Diabetes Mellitus and Foot Osteomyelitis, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by University Hospital, Montpellier · Observational
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.
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.
Diabetic patients admitted in hospital for foot osteomyelitis
Exclusion criteria:
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
The difference of time between usual cultures and PCR multiplex tests to identify responsible bacteria will be assessed
Time frame: 12-48 hours
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
Time frame: 12-96 hours
Plan to share: Undecided — NC
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier