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:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT06637904
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Participant presents to ED with ALL of the below:
2.1. Suspected acute infection (e.g., respiratory, urinary, abdominal, skin \& soft-tissue infection, meningitis/encephalitis, or any other infection), and 2.2. Either heart rate \>100 beats per minute or/and temperature \>38C. 2.3. NOT immediately roomed in a primary designated treatment location,( i.e., they can be in the waiting room, ED triage hallways, and/or ED staging area/fast track area).
3. Able to provide informed consent, or consent by legally authorized representative.
4. Reachable via confirmed working cell phone (with backup contact number) and willing to respond to follow-up safety checks (see below for details).
Exclusion Criteria:
1. Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to presentation in the waiting room of the ED. Participants will not be excluded for use of:
1. Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B and hepatitis C
2. Topical antibiotics, topical antivirals or topical antifungal agents
3. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
4. Single dose of one or combination of peri-operative (prophylactic) antibiotics
2. Patients receiving palliative or hospice care, or those receiving limited interventional care (see Appendix B).
3. Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
4. Participants receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines. Participants that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
5. Participants previously enrolled in the present clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06637904
Study Brief:
Protocol Section:
NCT06637904