A rapid DNA-test for early detection of bloodstream infections in intestinal failure patients
Recruiting
- Conditions
- Intestinal failure
- Registration Number
- NL-OMON23613
- Lead Sponsor
- MLDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 125
Inclusion Criteria
•Clinical suspicion of a bloodstream infection.
•Written informed consent before entering study.
Exclusion Criteria
•Intestinal failure patients <18 years of age.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is the sensitivity of the ddPCR to detect pathogens in blood compared with the gold standard.
- Secondary Outcome Measures
Name Time Method •Specificity of ddRST.<br>•Positive/negative predictive values of ddRST<br>•Positive/negative likelihood ratios of ddRST. <br>•Sensitivity/specificity of ddRST:<br> oin patients who received antibiotics =3 days before presentation. <br> oin patients who received antibiotics =7 days before presentation. <br> ofor detecting Gram-positive bacteria.<br> ofor detecting Gram-negative bacteria.<br> ofor detecting fungi.<br> oin relation to sepsis severity (sepsis versus septic shock)<br> o compared to follow-up bloodcultes<br>