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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97107018
Enrollment
4536
Registered
2013-10-25
Start date
2012-08-01
Completion date
Unknown
Last updated
2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Infection

Interventions

Once a positive blood culture has been identified patients meeting the inclusion criteria will be randomised 1:1 to receive conventional diagnosis or rapid diagnosis. A web-based randomisation system

Sponsors

North Bristol NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. To assess the impact of rapid diagnosis on all-cause mortality at 7 days 2. To assess the impact of rapid diagnosis on resolution of infection, measured by temperature 3. To assess the impact of rapid diagnosis on patient length of stay (days) 4. To assess the impact of rapid diagnosis on acquisition of Clostridium difficile infection within 28 days 5. To assess the impact of rapid diagnosis on in-hospital antibiotic consumption in the first 7 days 6. To assess the impact of rapid diagnosis on the NHS costs and cost-effectiveness of acute care 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 8. To investigate the relationship between the timing of appropriate antibiotic therapy and clinical outcomes

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026