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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT00515034
Eligibility Criteria:
Inclusion Criteria:
* Patients must be hospitalized with a diagnosis of Ventilator-Assisted Pneumonia (VAP) or complicated Intra-Abdominal Infection (cIAI)
* Patients with VAP must have been hospitalized (or been in a chronic care facility) for \>= 5 days, have received mechanical ventilation for \>= 48 hours, have a Clinical Pulmonary Infection Score (CPIS) of \>= 5, have new or progressive radiographic infiltrates (not related to another disease process)
* Patients with cIAI must have clinical evidence of intra-abdominal infection, abdominal pain or tenderness, localized or diffuse abdominal wall rigidity, mass, ileus or have a requirement for surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of study entry
Exclusion Criteria:
* Patients with a history of acute hepatic failure or acute decompensation of chronic hepatic failure, history of severe impairment of renal function, history of immunocompromising illness, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV) with a CD4 count less than 200 cells/mL within the past 6 months
* organ (including bone marrow) transplant recipients
* hematologic malignancy
* use of immunosuppressive therapy at screening, including use of high dose corticosteroids (e.g., \> 40 mg prednisone or equivalent per day for \> 2 weeks)
* history of any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure and septic shock)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00515034
Study Brief:
Protocol Section:
NCT00515034