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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT01808092
Eligibility Criteria:
Inclusion Criteria:
* 18 to 90 years of age inclusive
* Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after
* Onset of symptoms ≥ 48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility
* New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization
* At least 1 of the following systemic signs:Fever (temperature \>38 C) or hypothermia (rectal/core temperature \<35 C); White blood cell count \>10,000 cells/mm3, or White blood cell count \<4500 cells/mm3, or \>15% band forms.
Exclusion Criteria:
* Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
* Patients with lung abscess, pleural empyema or post obstructive pneumonia.
* Patients with an estimated creatinine clearance \<16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
* Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
* Patients receiving hemodialysis or peritoneal dialysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01808092
Study Brief:
Protocol Section:
NCT01808092