Skip to main content
OpenTrials
Completed

NCT Number: NCT04026035

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Aquitaine Microbiologie

Registry information

Acronym: PCRDial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2019
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.