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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT05393505
Eligibility Criteria:
Inclusion Criteria:
* Age criteria: 18 years old or above; AND
* Body temperature criteria: Tympanic temperature ≥ 38.3 degree Celsius (100.9 degree Fahrenheit) within 24 hours before emergency department registration; AND
* Chemotherapy timeframe criteria: Last chemotherapy or targeted therapy within 6 weeks for any solid tumor, or in any period following therapies against leukemia, lymphoma, myelodysplastic syndrome, aplastic anemia, multiple myeloma, or recipient of hematopoietic stem cell transplantation; AND
* Modified Early Warning Score (MEWS) ≤ 4
Exclusion Criteria:
* Unable to provide informed consent
* Previous enrolment to this trial within 180 days, or without current resolution of the first episode
* Enrolment to other interventional trials within 187 days
* Sepsis or septic shock
* Suspected central nervous system infection
* Severe desaturation (SpO2 \< 88% in room air for patients with chronic obstructive pulmonary disease, severe chest wall or spinal disease, neuromuscular disease, severe obesity, cystic fibrosis, bronchiectasis; or \< 94% in room air without)
* Currently on prophylactic antibiotic
* Any antibiotic treatment for \> 48 h within 1 week
* Known human immunodeficiency virus infection
* Primary humoral immunodeficiency
* Complement deficiency
* Asplenia
* Vulnerable subjects (illiterate, pregnancy, mentally incapacitated, impoverished, prisoner, subordinate or students of investigators, ethnic minorities)
* Research staff not available
* Unable to randomize within 1 hour of emergency department registration
* Inter-hospital transfer
* Scheduled "clinical" admissions
* Body temperature not documented
* Blood sample not taken in emergency department
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05393505
Study Brief:
Protocol Section:
NCT05393505