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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)

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ClinicalTrials.gov Identifier: NCT03434288
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Mellitus Foot Osteomyelitis Other: Bone sampling

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.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Evaluation of PCR Multiplex Tests for a Rapid Diagnosis of Bone Infections in Diabetic Foot
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patients admitted in hospital for foot osteomyelitis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434288


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Eric RENARD, MD, PhD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03434288    
Other Study ID Numbers: RECHMPL18_0013
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Diabetes
Diabetic foot
Osteomyelitis
Additional relevant MeSH terms:
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Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases