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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT02157259
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥30 days old and weighing at least 3 kg or more on the day of enrollment into the study
2. Required hospitalization as decided by the attending physician
3. Documented by attending physician that an infection is the primary cause of illness leading to the hospitalization. These can be infections due to any pathogens (bacteria, viruses, fungi and parasites).
4. Presence of Systemic Inflammatory Response Syndrome (SIRS):
4.1 For adults (≥ 18 years old), any combination of a minimum of any 3 of the following 20 parameters
* Fever or hypothermia (Core body temperature defined as \>38.3 C or \<36.0 C)
* Tachycardia (heart rate \>90 beats per minute)
* Tachypnea (respiratory rate \>20 per minute)
* Arterial hypotension (systolic blood pressure (SBP) \<90 mmHg, mean arterial pressure (MAP) \<70 mmHg, or SBP decrease \>40 mmHg)
* White blood cell (WBC) \>12,000 u/L or \<4000 u/L or immature forms \>10%
* Platelet count \<100,000 u/L
* Altered mental status with Glasgow Coma Score (GCS) \<15
* Hypoxemia (Pulse Oximetry Level \<95)
* Ileus
* Significant edema or positive fluid balance
* Decreased capillary refill or mottling
* Hyperglycemia (plasma glucose \>140 mg/dL) in the absence of diabetes
* Plasma C-reactive protein \>2 SD above the normal value
* Plasma procalcitonin \> 2 SD above the normal value
* Arterial hypoxemia (PaO2 / FIO2 \<300)
* Acute oliguria (urine output \<0.5 mL/kg/hr or 45 mmol/L for 2 hours)
* Creatinine increase \>0.5 mg/dL
* INR \>1.5 or a PTT \>60 seconds
* Plasma total bilirubin \>4 mg/dl or 70 mmol/L
* Hyperlactatemia (\>1 mmol/L)
4.2 For pediatric patients (\>30 days old and \<18 years old), all of the 3 following symptoms:
* Fever or hypothermia (rectal temperature defined as \>38.5 C or \<35.0 C \[or equivalent\])
* Tachycardia (heart rate \>2 SD above the normal value for age). This could be absent in hypothermic subject.
* Tachypnea (respiratory rate \>2 SD above the normal value for age)
AND at least one of the following parameters:
* Altered mental status,(e.g., drowsiness, poor quality of cry, poor reaction to parent stimuli, and poor response to social overtures)
* Systolic blood pressure \<2 SD below the normal value for age OR narrow pulse pressure (\<20 mmHg) OR poor perfusion (capillary refill \>2 sec)
* Hypoxemia (Pulse Oximetry Level \<95)
* White blood cell \>15,000 u/L or \<5,000 u/L or immature forms \>10%.
5. Informed Consent has been obtained.
Exclusion Criteria:
* Admitted to the study site hospital for this current episode for more than 24 hours before enrollment.
* Hospitalized for this current episode for more than 72 hours at another primary/referring hospital.
* Prior to this current episode, the subject was admitted to any hospital within the last 30 days.
* An underlying pre-existing condition is thought to have led to or contributed to this sepsis episode. For example, sepsis is considered to be directly attributable to existing non-infectious conditions such as stroke, cardiovascular diseases, acute myocardial infarction, cancer, burn, injury, and trauma.
* Prior to enrollment, it is documented by the attending physician that hospital acquired infection is associated with the cause of the sepsis or severe sepsis.
* The subject has been enrolled into this study or another sepsis study before.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Days
Study:
NCT02157259
Study Brief:
Protocol Section:
NCT02157259