Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

Not Applicable

Completed

• Conditions: Septic Shock; Bacteremia; Sepsis
• Interventions: Diagnostic Test: PathoRobot/ Patho-Doc Test result

• Registration Number: NCT04103203
• Lead Sponsor: Hasselt University

Brief Summary

The performance and clinical impact of two diagnostic systems will be evaluated using whole blood samples that are collected in parallel with samples for blood culture. As the rapid diagnostic systems will have the largest impact on severely ill patients (in need of a fast diagnosis) with bacterial infection, the evaluation will be performed in patients suspected of bacteraemia. During the study the new systems will be used in parallel with routine blood cultures. In alternating periods of 1 month, the results of the diagnostic system will be communicated to treating physicians (intervention) or not revealed (control). Blood culture results will be reported throughout the complete study period. Patients with suspected sepsis at the Emergency Department (ED), the department of infectious diseases/nephrology, and the department of haemodialysis will be included. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood sample (EDTA tube, 9 ml of blood) will be sampled for each routine set of blood cultures. In addition, the clinical data of the patients will be collected. The samples will be sent to the clinical laboratory where samples are tested with the new systems during regular working hours in batches of 8 samples per run (2-3 runs per day). On average, 10%-20% of the blood cultures drawn on the presumption of bacteraemia yield bacterial pathogens. Previous data show that 13% of patients yield positive blood cultures. Thus, in order to collect blood samples of 100 new episodes of bacteraemia approximately 1000 patients (2000 blood cultures + 1000 EDTA tubes) have to be collected for each system (2000 patients in total). The results of the systems will be used to evaluate the clinical utility of the system regarding time to antibiotic treatment change and bacteraemia management. The system will be used directly for the diagnosis of patients, resulting in a possible change of treatment strategy. However, routine blood culture practices will still be done during the whole study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1978

Inclusion Criteria

• Suspicion of sepsis
• The drawning of blood cultures
• Age >18 years

Exclusion Criteria

• Children (<18 years)
• Patients who are not hospitalized and sent home after ED admission
• Duplicate blood cultures from the same bacteraemia episode (7days between positives with the same organism, or 24h for different organisms)
• Patients from who blood cultures are drawn on Friday evening (17h) or Saturday during intervention periods

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New diagnostic results available	PathoRobot/ Patho-Doc Test result	Patients with suspected sepsis are included. Blood samples will be collected and analysed with the new diagnostics. Results will be communicated via telephone by the consultant microbiologist and the electronic medical file to the treating physician. Results of routine blood cultures will also be available for all patients. Results of the new diagnostics are expected earlier, and the treating physician is able to make an earlier decision in terms of antibiotic therapy if he/she deems it necessary.

Primary Outcome Measures

Name	Time	Method
Median time from specimen collection/arrival in the laboratory until antibiotic regimen change	at study completion, 10 months	Time period between collection of blood cultures until the first change in antibiotic regimen

Secondary Outcome Measures

Name	Time	Method
Median time to appropriate, species-specific antibiotic therapy	at study completion, 10 months	Time period between collection of blood cultures until the first administration of species-specific antibiotic therapy
30-day all cause mortality	at study completion, 10 months	Number of patients with 30-day all cause mortality
In-hospital mortality	at study completion, 10 months	In-hospital mortality
Time to organism identification	at study completion, 10 months	Time period between collection of blood cultures until the time to identification of a causative organism with the new diagnostics and with blood cultures
Length-of-stay	at study completion, 10 months	Length of hospital stay
Time to effective therapy	at study completion, 10 months	Time period between collection of blood cultures until the first administration of antibiotic therapy effective againts the causative organism
Destination at Discharge	at study completion, 10 months	Destination after discharge (home, rehabilitation home, nursing home, ...)
Time to optimal therapy	at study completion, 10 months	Time period between collection of blood cultures until the first administration of antibiotic therapy that is optimal for patient recovery
Length of ICU stay	at study completion, 10 months	Length of stay in an Intensive Care Unit

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium