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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses

Participation Criteria

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

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".

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours after inclusion visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours after inclusion visit

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Aquitaine Microbiologie
• Investigators: Study Chair: Fatima M'ZALI, Dr, Aquitaine Microbiologie

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): March 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: PCR; septicemia; hemoculture
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: CHUBX 2019/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No