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

Completed

• Conditions: Septicemia in Hemodialysis

• Registration Number: NCT04026035
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-19
• Study Start: 2019-08-01
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the bacterial species concordance between the diagnostic laboratory approach and the novel approach	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

Name	Time	Method
Evaluate the concordance of meticillin resistance diagnosis between PCR and blood cultures	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.

Trial Locations

Locations (1)

Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses; 🇫🇷 Bordeaux, France