Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT05305534
Eligibility Criteria:
Inclusion Criteria:
* Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU.
* Residual and de-identified specimens.
* Specimen from subject who has not previously been enrolled.
* Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity.
* Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity.
* Minimum 1.5 mL volume available
* In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales.
Exclusion Criteria:
* Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids)
* Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected).
* Frozen specimens which are unable to be cultured after thawing.
* Specimen from subject previously enrolled
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05305534
Study Brief:
Protocol Section:
NCT05305534