A prospective randomised, multicentre trial to assess the impact of laboratory based rapid diagnosis on outcome in patients with Blood Stream Infections

Not Applicable

Completed

• Conditions: Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN97107018
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-25
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4536

Inclusion Criteria

1. Age 18 years and over
2. Male and female
3. Blood culture positive for bacteria or fungi
4. Admitted to hospital

Exclusion Criteria

1. Less than 18 years of age
2. Patients on the end of life pathway when the blood sample was taken
3. Previously randomised for this study as each patient will only be recruited once
4. Prisoners or young offenders in the custody of HM Prison Service in England or Wales.
5. Patients not recieving NHS care
6. Attending physician deems patient unsuitable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the impact of laboratory based rapid diagnosis of Blood Stream Infections on 28-day all-cause mortality.

Secondary Outcome Measures

Name	Time	Method
1. To assess the impact of rapid diagnosis on all-cause mortality at 7 days<br>2. To assess the impact of rapid diagnosis on resolution of infection, measured by temperature<br>3. To assess the impact of rapid diagnosis on patient length of stay (days)<br>4. To assess the impact of rapid diagnosis on acquisition of Clostridium difficile infection within 28 days<br>5. To assess the impact of rapid diagnosis on in-hospital antibiotic consumption in the first 7 days<br>6. To assess the impact of rapid diagnosis on the NHS costs and cost-effectiveness of acute care<br>7. To assess the impact of rapid diagnosis on time to initiation of appropriate antibiotic therapy and time to appropriate de-escalation of empirical broad-spectrum antibiotic therapy<br>8. To investigate the relationship between the timing of appropriate antibiotic therapy and clinical outcomes