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 @ 1:52 PM
Ignite Modification Date:
2025-12-24 @ 1:52 PM
NCT ID:
NCT04516395
Eligibility Criteria:
Inclusion Criteria:
1. Any patients are diagnosed any diseases caused by CRE infection by physicians at Phramongkutklao hospital during 1/4/2018 to 30/4/2021.
2. Any patients are more than 18 years old.
3. Any patients have at least 1 criterion as following 3.1 Any patients have at least 2 of the signs and symptoms of Systemic inflammatory response syndrome (SIRS), including
* Fever (temperature \> 38 °C) or hypothermia (temperature \< 36°C)
* Tachypnea (heart rate \> 90 beats per minute)
* Respiratory rate \> 20 beats per minute or Paco2 \< 32 mm Hg (4.3 kPa)
* White blood cell count \> 12,000 cells per millilitre (leukocytosis) or \< 4,000 cells per milliliter (leukopenia) 3.2. Any patients are diagnosed with sepsis or have ≥ 2 points of Sequential Organ Failure Assessment (SOFA) Score or qSOFA (Quick SOFA) Score.
3.3. Any patients are diagnosed with septic shock or are received vasopressors (eg, dopamine, norepinephrine, epinephrine, vasopressin, phenylephrine), mean arterial pressure (MAP) \< 65 mm Hg, and lactate \> 2 mmol/L (18 mg/dL) 3.4 Any patients are received mechanical ventilation 3.5 Any patients are admitted at ICU ward.
Exclusion Criteria:
1. Patients are breast-feeding or pregnancy.
2. Patients are insufficient or incomplete information on the medical electronic record such as patients transferred.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04516395
Study Brief:
Protocol Section:
NCT04516395