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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03434288
Acronym
RAPDIAGOS
Enrollment
48
Registered
2018-02-15
Start date
2018-02-08
Completion date
2019-12-01
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Foot Osteomyelitis

Keywords

Diabetes, Diabetic foot, Osteomyelitis

Brief summary

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

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.

Interventions

OTHERBone sampling

Bone biopsy in Diabetic patients with foot osteomyelitis

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time for identification of bacteria responsible for foot osteomyelitis12-48 hoursThe difference of time between usual cultures and PCR multiplex tests to identify responsible bacteria will be assessed

Secondary

MeasureTime frameDescription
Time for identification of sensitivity/resistance to antibiotics of the bacteria responsible for foot osteomyelitis12-96 hoursThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026