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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00410527
Eligibility Criteria:
* INCLUSION CRITERIA:
The study will be limited to the medical, surgical, neurosurgical, trauma, and general ICUs of the participating institutions. Burn ICUs are not eligible for this study.
Subjects who meet all of the following criteria are eligible for enrollment into the study:
1. Subject, or legal representative, has given written informed consent.
2. Subject has developed a new pulmonary infiltrate (confirmed by radiology), after ICU admission.
3. Subject has been hospitalized at least 3 days.
4. CPIS less than or equal to 6.
5. 18 years of age or older.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria are ineligible for participation in the study:
1. Burn patients.
2. Cystic fibrosis patients.
3. Bone marrow or solid organ transplant patients.
4. Neutropenia from any cause (absolute neutrophil count (ANC) \< 500), or likely to become neutropenic within 7 days.
5. Known or suspected Human Immunodeficiency Virus (HIV) infection (HIV test is not required).
6. Suspected or proven extrapulmonary infection site requiring antibiotic therapy.
7. History of anaphylaxis to penicillin or cephalosporins.
8. History of anaphylaxis to meropenem (any component of the formulation), or other carbapenems (e.g., imipenem).
9. On systemic antibiotics for more than 7 consecutive days during the previous 30 days.
10. Received more than two doses of systemic antibiotics within the past 24 hours (other than those used for surgical prophylaxis).
11. Pregnant or lactating. (Women of childbearing potential must have a negative serum or urine pregnancy test within the 7 days prior to the first dose of antibiotics.)
12. On mechanical ventilation for \> 7 consecutive days during the previous 30 days.
13. Unlikely to survive past Day 7 of the study (as determined by the primary care team).
14. Previous enrollment in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00410527
Study Brief:
Protocol Section:
NCT00410527