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:
2025-12-17 @ 2:48 PM
Ignite Modification Date:
2025-12-22 @ 2:26 PM
NCT ID:
NCT04747795
Eligibility Criteria:
Inclusion Criteria:
* Patient has a 'suspected infection': this requires the combination of antibiotic administration and body fluid cultures within the first 6 hours after Emergency Department presentation.
* Patient has a NEWS score ≥ 5.
Exclusion Criteria:
* Patient (≥18 years old) or legally authorized representative didn't provide informed consent. Delayed informed consent can be applied in cases where the patient is critically ill and no LAR is available.
* antibiotic administration as a single dose or as a prophylactic treatment.
* antibiotics administered without an accompanying body fluid culture according to the timeframe (within 6 hours after emergency department presentation).
* 'Do no intubate' or 'comfort measures only' status.
* Failure to randomize within 6 hours after Emergency Department presentation.
* Weight \< 45 kg.
* Pregnant or breastfeeding.
* Known allergy for Vitamin C.
* Known history of oxalate nephropathy or hyperoxaluria.
* Known history of glucose-6-phosphate dehydrogenase deficiency.
* Known history of chronic iron overload due to iron storage and other diseases.
* The patient is already on IV steroids for a reason other than septic shock.
* Proven active COVID-19 infection (positive swab and/or CT scan positive for COVID-19 within 14 days prior to or at ED presentation).
* Participation in an interventional trial with an investigational medicinal product (IMP) or device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04747795
Study Brief:
Protocol Section:
NCT04747795