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
|Condition or disease|
|Septicemia in Hemodialysis|
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|
|Actual Enrollment :||51 participants|
|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|
- 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.
- 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
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
|Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses|
|Bordeaux, France, 33000|
|Study Chair:||Fatima M'ZALI, Dr||Aquitaine Microbiologie|