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

Septicemia in Hemodialysis Clinical Trial

— PCRDial  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026035
• Other study ID #: CHUBX 2019/01
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Septicemia in Hemodialysis
• Toxemia

Locations

Country	Name	City	State
France	Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Aquitaine Microbiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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