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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT00438269
Eligibility Criteria:
Inclusion Criteria:
* In hospital \> 72 hrs and in ICU \> 24hrs, and
* Core temperature ≥38.5°C, or temperature ≥ 38.0°C with a WBC\>12,000/mm3, or temperature ≤ 36.0°C with a WBC \> 12,000/mm3
* Suspicion of infection
Exclusion Criteria:
* Age \< 18 years
* Imminent death (within 24 hrs) or withdrawal of aggressive therapy
* Prosthetic heart valve or vascular graft
* Neutropenia (Absolute neutrophil count \< 1000/mm3)
* Received \> 16 hours of a broad spectrum antibiotic in the last 24 hours (3rd gen cephalosporin, fluoroquinolone, carbapenem, anti-pseudomonal penicillin) or any combination therapy
* History of allergic reaction to both study medications
* New physical findings consistent with infection:
* Meningeal signs
* Peritonitis + free air on Abdo x-ray
* Soft tissue infection / cellulitis
* Murmur \& suspicion of endocarditis
* Newly available (within past 24 hours) culture results consistent with infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00438269
Study Brief:
Protocol Section:
NCT00438269