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PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter. (PCRDial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026035
Recruitment Status : Completed
First Posted : July 19, 2019
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
Aquitaine Microbiologie
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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. The results obtained with this novel experimental approach will be compared to those obtained on the same clinical samples by the routine diagnostic laboratory.

Condition or disease
Septicemia in Hemodialysis

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.

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter.
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : March 5, 2020
Actual Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Sepsis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluate the concordance of meticillin resistance diagnosis between PCR and blood cultures [ Time Frame: 48 hours after inclusion visit ]
    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.


Biospecimen Retention:   Samples Without DNA
whole blood


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

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".

Criteria

Inclusion Criteria:

  • patients over 18 year old,
  • suspicion of septicemia in hemodialysis patient with catheter,
  • patient oral consent prior to inclusion in the study.

Exclusion Criteria:

  • patients who went through the A&E department,
  • patients who have received an antimicrobial therapy more than 8 hours long,
  • patient under legal protection.

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): NCT04026035


Locations
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France
Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Aquitaine Microbiologie
Investigators
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Study Chair: Fatima M'ZALI, Dr Aquitaine Microbiologie
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04026035    
Other Study ID Numbers: CHUBX 2019/01
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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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, Bordeaux:
PCR
hemoculture
septicemia
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes