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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00236834
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hospital-acquired pneumonia as follows: hospitalization \>= 48 but \<= 72 hours, identification of a bacteria commonly found in hospital-acquired infections, absence of pneumonia on initial chest x-ray, normal white blood cell count, and diagnosis other than infection upon admission to hospital OR hospitalized \>= 72 hours OR discharged from a hospital \<= 48 hours after a hospitalization of \>= 72 hours AND chest x-ray findings consistent with infection AND abnormal temperature (high or low) or abnormal white blood cell count
* Specimen from respiratory tract is available for laboratory analysis
* APACHE score \<= 35
* Have received at least 72 hours of treatment with antibiotics administered intravenously (through a vein) and have failed that treatment providing the previous drugs were not levofloxacin or imipenem/cilastatin and there is evidence of failure (specimen from respiratory tract documenting original bacteria causing pneumonia is still present or presence of a new bacteria causing pneumonia acquired in the hospital, continued abnormal temperature or worsening of x-ray findings and at least 1 of the following: increased white blood cell count or decrease in breathing ability/increase in oxygen requirements)
* Have received treatment with antibiotics administered intravenously (through a vein) for \< 24 hours within 72 hours prior to study entry
* Hospitalized for \>= 72 hours and develop acute signs and symptoms of pneumonia while on antibiotic(s) for another reason, providing that the previous antibiotic(s) were not levofloxacin or imipenem/cilastatin, no antibiotics have been given for the pneumonia and the previous antibiotic(s) can be discontinued
Exclusion Criteria:
* Infection due to a bacteria that is know to be resistant to levofloxacin or imipenem or certain other drugs that may be used during the study
* Have received treatment with antibiotics administered intravenously for \> 24 hours within 72 hours prior to study entry
* Previous allergic or serious adverse reaction to any of the drugs used in this study or to a drug similar to those used in this study
* Cystic fibrosis or other lung disorder or an infection not treatable with antibiotics
* Significantly decreased kidney function
* Pre-infection terminal illness (such as cancer)
* Decreased white blood cell count
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00236834
Study Brief:
Protocol Section:
NCT00236834