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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 (RAPDIAGOS)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Foot Osteomyelitis
Diabetes Mellitus

Treatments

Other: Bone sampling

Study type

Observational

Funder types

Other

Identifiers

NCT03434288
RECHMPL18_0013

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Diabetic patients with foot osteomyelitis
Description:
Biological and MRI signs of foot osteomyelitis
Treatment:
Other: Bone sampling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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