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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT05955612
Eligibility Criteria:
Inclusion Criteria:
* Participant, legally authorised person/ legal guardian willing and able to give informed consent for participation in the trial.
* Male or Female, aged 16 to 65 years
* Suspected or proven bacterial infection
* A positive sepsis screening National Early Warning Score (NEWS) equal or greater than 5 (Table 1 or at least one criterion with a score of 3.
* Intention to start parenteral antibiotic therapy
* Within 24 hours of hospital admission
Exclusion Criteria:
* Patients with suspected/documented tuberculosis, parasitic infection (including malaria or visceral leishmaniasis), or viral infections (i.e., COVID-19, dengue, HIV)
* Pregnancy
* Intended for a short stay in ICU or general ward (such as post-operative)
* Patients requiring a predefined long course of antibiotic therapy (such as endocarditis, osteomyelitis, lung abscess, liver abscess, septic arthritis)
* Immunocompromised patients, including as severe neutropenia (\< 500 cells/ml), transplant recipients, on prolonged corticosteroid treatment, chemotherapy or disease modifying immunomodulatory medications
* More than 48 hours of parenteral antibiotic use
* Surgical patients, including patients with a surgical septic source or patients requiring source control, i.e. abscess drainage
* Moribund patients or patients receiving end of life care
* Previous enrolment in PROCALBAN
* Conditions accompanied with a systemic inflammatory state, including pancreatitis, cardiogenic shock, severe trauma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT05955612
Study Brief:
Protocol Section:
NCT05955612