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

June 4, 2020 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic patients admitted in hospital for foot osteomyelitis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic patients with foot osteomyelitis
Biological and MRI signs of foot osteomyelitis
Other: Bone sampling
Bone biopsy in Diabetic patients with foot osteomyelitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Eric RENARD, MD, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2018

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (ACTUAL)

February 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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