Diabetes MellitusRAPDIAGOSNCT03434288
Assessment of PCR Multiplex Tests as a Tool to Obtain a Quicker Diagnosis of Bacteria Responsible for Foot Osteomyelitis Than Usual Cultures
An observational study of Diabetes Mellitus and Foot Osteomyelitis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Foot Osteomyelitis
- What is being tested?
- Bone sampling
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients admitted in hospital for foot osteomyelitis
Who may be able to join
- Biological and MRI signs of foot osteomyelitis
- Indication of bone biopsy
- No antibiotics since 2 weeks
Who cannot join
- Antibiotic therapy
- Previous cultures for the same infectious event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Foot Osteomyelitis
- Being tested
- Bone sampling
- Keywords
- Diabetes, Diabetic foot, Osteomyelitis
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone samplingOther
Bone biopsy in Diabetic patients with foot osteomyelitis
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with foot osteomyelitis | Biological and MRI signs of foot osteomyelitis Receives: Other: Bone sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12-48 hours
Secondary outcomes (1)
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
Measured: 12-96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start8 Feb 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric RENARD, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434288
- Sponsor's protocol ID
- RECHMPL18_0013
- Acronym
- RAPDIAGOS
- Status last verified
- Jun 2020
- First submitted
- 26 Jan 2018
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of PCR Multiplex Tests for a Rapid Diagnosis of Bone Infections in Diabetic Foot
- ClinicalTrials.gov ID
- NCT03434288
- Acronym / sponsor ID
- RAPDIAGOS / RECHMPL18_0013
- Conditions
- Diabetes Mellitus, Foot Osteomyelitis
- Keywords
- Diabetes, Diabetic foot, Osteomyelitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with foot osteomyelitis | – | Other: Bone samplingBiological and MRI signs of foot osteomyelitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients admitted in hospital for foot osteomyelitis
Key inclusion criteria (3 listed)
- Biological and MRI signs of foot osteomyelitis
- Indication of bone biopsy
- No antibiotics since 2 weeks
Key exclusion criteria (2 listed)
- Antibiotic therapy
- Previous cultures for the same infectious event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone samplingBone biopsy in Diabetic patients with foot osteomyelitis | Other | Diabetic patients with foot osteomyelitis |
Primary outcome
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
1 secondary outcome
Time for identification of sensitivity/resistance to antibiotics of the bacteria responsible for foot osteomyelitis
Time frame: 12-96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric RENARD, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Foot Osteomyelitis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for identification of bacteria responsible for foot osteomyelitis (time frame: 12-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.