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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT00258869
Eligibility Criteria:
Inclusion Criteria:
1\. Patient has known or acute infection or suspected infection AND patient must meet at least 2 of the following 4 criteria to be enrolled
1. A core temperature of \>= 38°C (100.4°F) or \<= 36°C (96.8°F)
2. Patients \> 18 years of age, Heart rate of \>= 90 beats/min Patients 13-18 years of age, Heart rate of \>= 110 beats/min Patients 6-12 years of age, Heart rate of \>= 130 beats/min
3. Patients \> 18 years of age, Respiratory rate of \>= 20 breaths/min Patients 13-18 years of age, Respiratory rate of \>= 14 breaths/min Patients 6-12 years of age, Respiratory rate of \>= 18 breaths/min OR PaCO2 of \<= 32 mm Hg OR Use of Mechanical Ventilation for an acute respiratory process
4. Patients \> 18 years of age, White cell count \>= 12,000/mm3 or \<= 4,000/mm3 Patients 13-18 years of age, White cell count \>= 11,000/mm3 or \<= 4,500/mm3 Patients 6-12 years of age, White cell count \>= 13,500/mm3 or \<= 4,500/mm3 OR A differential count showing \> 10% immature neutrophils
Exclusion Criteria:
1. Patient is less than 6 years of age.
2. Patient is not expected to survive 28 days because of uncorrectable medical condition (apart from pneumonia or sepsis), such as poorly controlled neoplasm or other end-stage disease, or patient has active DNR order
3. Human immunodeficiency virus (HIV) infection with a last known CD4 count of \<50 mm3
4. Acute presence of a cerebral vascular event, active gastrointestinal hemorrhage, seizure (acute episode), drug overdose, burn injury, trauma
5. Patient is pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT00258869
Study Brief:
Protocol Section:
NCT00258869