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

Diabetes Mellitus Clinical Trial

— RAPDIAGOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434288
• Other study ID #: RECHMPL18_0013
• Status: Completed
• Start date: February 8, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Foot Osteomyelitis
• Osteomyelitis

Intervention

Other:
• Bone sampling
Bone biopsy in Diabetic patients with foot osteomyelitis

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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