Septicemia in HemodialysisPCRDialNCT04026035
PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter.
An observational study of Septicemia in Hemodialysis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aims of this study are to evaluate the PCR on whole blood approach to determine rapidly both the susceptibility and the identification of Staphylococcus responsible of septicemia in patients under hemodialysis with catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septicemia in Hemodialysis
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 5 Mar 2020
- 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: Patients are treated in hemodialysis in the Nephrology Transplantation Dialysis Department of the Pellegrin Hospital of Bordeaux University Hospital. The hemodialysis unit of this service, supports a constant cohort of dialysis patients three times a week (Monday / Wednesday / Friday or Tuesday / Thursday / Saturday). Sepsis can occur during a hemodialysis session or be the cause of hospitalization. During an infectious episode, the patient is informed orally of the study and gives his oral and written consent to take an additional tube in order to carry out a bacteriological complementary analysis using a new technique to compare it to the "gold standard".
Who may be able to join
- patients over 18 year old,
- suspicion of septicemia in hemodialysis patient with catheter,
- patient oral consent prior to inclusion in the study.
Who cannot join
- patients who went through the A\&E department,
- patients who have received an antimicrobial therapy more than 8 hours long,
- patient under legal protection.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses
Bordeaux, 33000
About this study
The aims of this study are to evaluate the PCR on whole blood approach to determine rapidly both the susceptibility and the identification of Staphylococcus responsible of septicemia in patients under hemodialysis with catheter. The results obtained with this novel experimental approach will be compared to those obtained on the same clinical samples by the routine diagnostic laboratory.
Read the detailed description
The outlook of current trends indicates that maximum effort is needed to tailor the initial antimicrobial therapy in patients under hemodialysis with catheter. Specific emphasis is put on early availability of antimicrobial susceptibility results by Diagnostic laboratories to optimize the management of those difficult infections.
Direct whole blood PCR could allow a rapid determination of bacterial susceptibility to antibiotics. The study is designed to assess the concordance of a direct whole blood PCR targeting staphylococcus and its susceptibility to oracillin with the classical microbiological approach of samples from hemodialysis patients with catheter suspected of septicemia. This innovative approach should allow a faster diagnostic allowing the clinicians to better tailor the initial empirical antimicrobial therapy which has been proven crucial for a good clinical management of the patients.
Moreover, the use of an adequate antimicrobial therapy early in the management of the patients, should not only lead to a better clinical outcome but also avoid unnecessary prescriptions of drugs which are the main drivers of the emergence and spread of antimicrobial resistance.
- Conditions
- Septicemia in Hemodialysis
- Keywords
- PCR, hemoculture, septicemia
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the bacterial species concordance between the diagnostic laboratory approach and the novel approach
The bacterial contamination will be estimated by the results of hemoculture compared to the PCR approach. The concordance between the two profils will be observed.
Measured: 48 hours after inclusion visit
Secondary outcomes (1)
Evaluate the concordance of meticillin resistance diagnosis between PCR and blood cultures
The meticillin resistance diagnosis will be estimated by the result of PCR approach and blood cultures in hemodialysis patients with renal insufficiency with a suspected sepsis.
Measured: 48 hours after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Aug 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septicemia in HemodialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Aquitaine Microbiologie
- Responsible party
- Sponsor
- Investigators
- Fatima M'ZALI, Dr, Study chair, Aquitaine Microbiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026035
- Sponsor's protocol ID
- CHUBX 2019/01
- Acronym
- PCRDial
- Status last verified
- May 2020
- First submitted
- 16 Jul 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter.
- ClinicalTrials.gov ID
- NCT04026035
- Acronym / sponsor ID
- PCRDial / CHUBX 2019/01
- Conditions
- Septicemia in Hemodialysis
- Keywords
- PCR, hemoculture, septicemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Aquitaine Microbiologie
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 19 Jul 2019 (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.
The aims of this study are to evaluate the PCR on whole blood approach to determine rapidly both the susceptibility and the identification of Staphylococcus responsible of septicemia in patients under hemodialysis with catheter. The results obtained with this novel experimental approach will be compared to those obtained on the same clinical samples by the routine diagnostic laboratory.
Detailed description
The outlook of current trends indicates that maximum effort is needed to tailor the initial antimicrobial therapy in patients under hemodialysis with catheter. Specific emphasis is put on early availability of antimicrobial susceptibility results by Diagnostic laboratories to optimize the management of those difficult infections.
Direct whole blood PCR could allow a rapid determination of bacterial susceptibility to antibiotics. The study is designed to assess the concordance of a direct whole blood PCR targeting staphylococcus and its susceptibility to oracillin with the classical microbiological approach of samples from hemodialysis patients with catheter suspected of septicemia. This innovative approach should allow a faster diagnostic allowing the clinicians to better tailor the initial empirical antimicrobial therapy which has been proven crucial for a good clinical management of the patients.
Moreover, the use of an adequate antimicrobial therapy early in the management of the patients, should not only lead to a better clinical outcome but also avoid unnecessary prescriptions of drugs which are the main drivers of the emergence and spread of antimicrobial resistance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are treated in hemodialysis in the Nephrology Transplantation Dialysis Department of the Pellegrin Hospital of Bordeaux University Hospital. The hemodialysis unit of this service, supports a constant cohort of dialysis patients three times a week (Monday / Wednesday / Friday or Tuesday / Thursday / Saturday). Sepsis can occur during a hemodialysis session or be the cause of hospitalization. During an infectious episode, the patient is informed orally of the study and gives his oral and written consent to take an additional tube in order to carry out a bacteriological complementary analysis using a new technique to compare it to the "gold standard".
Key inclusion criteria (3 listed)
- patients over 18 year old,
- suspicion of septicemia in hemodialysis patient with catheter,
- patient oral consent prior to inclusion in the study.
Key exclusion criteria (3 listed)
- patients who went through the A\&E department,
- patients who have received an antimicrobial therapy more than 8 hours long,
- patient under legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the bacterial species concordance between the diagnostic laboratory approach and the novel approach
Time frame: 48 hours after inclusion visit
The bacterial contamination will be estimated by the results of hemoculture compared to the PCR approach. The concordance between the two profils will be observed.
1 secondary outcome
Evaluate the concordance of meticillin resistance diagnosis between PCR and blood cultures
Time frame: 48 hours after inclusion visit
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 13 May 2020.
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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.
Fatima M'ZALI, Dr study chair
Aquitaine Microbiologie
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 Septicemia in Hemodialysis, run by University Hospital, Bordeaux 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 3 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 13 May 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?
Estimate the bacterial species concordance between the diagnostic laboratory approach and the novel approach (time frame: 48 hours after inclusion visit). 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 13 May 2020.