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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT05336851
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for enrolment include:
With reference to previous inclusion criteria are:
* Adults ≥18 years of age; AND
* Suspected, acute, community-acquired, respiratory, infectious disease (scaRID)\*; AND
* Informed consent.
Note: scaRID is defined according to ALL three criteria:
1. Community acquired (not hospitalised for \<28 days); AND
2. Acute infection (defined as symptom onset \<8 days and any ONE of reported fever or chills or aural temperature \>37.5°C or hypothermia or leucocytosis or leucopaenia or new altered mental status); AND
3. Probable respiratory infection - According to any ONE of:
1. new cough or new sputum production or
2. chest pain or
3. dyspnoea or
4. tachypnoea or
5. abnormal lung examination or
6. respiratory failure; or
7. physician's judgment (presenting with systemic or gastrointestinal symptoms).
Control subjects will be drawn from two groups:
* The worried well - adult patients with a National Early Warning Score (NEWS) \<3 and a temperature \<37.5°C.
* Relatives or accompanying friends with no acute illness.
Exclusion Criteria:
* Refusal of consent;
* Recent hospitalisation (\<28 days);
* Enrolled in another clinical trial
* Cellulitis;
* Skin or orthopaedic infections;
* Urinary tract infection;
* Acute abdominal sepsis;
* Sexual transmitted disease;
* Human immunodeficiency virus (HIV) infection;
* Immunocompromised/potential neutropenic fever;
* Solid organ or haematopoietic stem-cell transplant within the previous 90 days;
* Active graft-versus-host disease or bronchiolitis obliterans;
* Severe traveller's disease requiring urgent hospitalisation and management including malaria, dengue, typhoid and other rickettsial diseases;
* Stroke;
* Toxidrome;
* Non-organic acute psychosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05336851
Study Brief:
Protocol Section:
NCT05336851