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

Completed

• Conditions: Diabetes Mellitus; Foot Osteomyelitis
• Interventions: Other: Bone sampling

• Registration Number: NCT03434288
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2018-01-26
• Study Start: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients with foot osteomyelitis	Bone sampling	Biological and MRI signs of foot osteomyelitis

Primary Outcome Measures

Name	Time	Method
Time for identification of bacteria responsible for foot osteomyelitis	12-48 hours	The difference of time between usual cultures and PCR multiplex tests to identify responsible bacteria will be assessed

Secondary Outcome Measures

Name	Time	Method
Time for identification of sensitivity/resistance to antibiotics of the bacteria responsible for foot osteomyelitis	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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France