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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01667094
Eligibility Criteria:
Inclusion Criteria:
1. Patients \>= 18 years of age,
2. Pseudomonas aeruginosa isolated in sputum within the last 12 months,
3. has an acute infective exacerbation, defined by international standards of 2 or more of the following in the last 2 weeks:
* change sputum volume or colour,
* increased cough,
* increased dyspnoea,
* increased malaise, fatigue or lethargy,
* anorexia or weight loss,
* decrease in pulmonary function by 10% or more, or
* new radiographic changes
Exclusion Criteria:
1. patients \< 18 yrs of age,
2. patients that do not meet the criteria for an acute infective exacerbation,
3. concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure,
4. impaired renal function with an estimated creatinine clearance \< 60 mls/min,
5. patients allergic to ß-lactam antibiotics,
6. aminoglycoside contra-indicated,
7. intravenous antibiotics in the last 2 weeks, prior to this admission,
8. received more than 24 hours of intravenous antibiotics in this admission,
9. previous lung transplantation,
10. pregnancy or lactation, or
11. inability to consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01667094
Study Brief:
Protocol Section:
NCT01667094