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Completed

NCT Number: NCT03434288

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone sampling

Other

Bone biopsy in Diabetic patients with foot osteomyelitis

Primary outcomes

  1. Time for identification of bacteria responsible for foot osteomyelitis

    Time frame: 12-48 hours

    The difference of time between usual cultures and PCR multiplex tests to identify responsible bacteria will be assessed

Secondary outcomes

  1. Time for identification of sensitivity/resistance to antibiotics of the bacteria responsible for foot osteomyelitis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: RAPDIAGOS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2018
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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