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A rapid DNA-test for early detection of bloodstream infections in intestinal failure patients

A rapid DNA-test for early detection of bloodstream infections in intestinal failure patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23613
Enrollment
125
Registered
2019-05-07
Start date
2019-05-06
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Intestinal failure

Interventions

Directly after collection of the first sets of blood cultures, two EDTA blood samples of 5 mL will be collected from the CVC and two 5 mL EDTA blood samples will be collected from the peripheral veins

Sponsors

MLDS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Clinical suspicion of a bloodstream infection. • Written informed consent before entering study.

Exclusion criteria

Exclusion criteria: • Intestinal failure patients <18 years of age.

Design outcomes

Primary

MeasureTime frame
Primary outcome is the sensitivity of the ddPCR to detect pathogens in blood compared with the gold standard.

Secondary

MeasureTime frame
• Specificity of ddRST. • Positive/negative predictive values of ddRST • Positive/negative likelihood ratios of ddRST. • Sensitivity/specificity of ddRST: o in patients who received antibiotics =3 days before presentation. o in patients who received antibiotics =7 days before presentation. o for detecting Gram-positive bacteria. o for detecting Gram-negative bacteria. o for detecting fungi. o in relation to sepsis severity (sepsis versus septic shock) o compared to follow-up bloodcultes

Contacts

Public ContactVeerle Gillis

Radboud umc

veerle.gillis@radboudumc.nl0650008466

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)