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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00153634
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CF based on the following: sweat chloride \> 60 mEq/L (by quantitative pilocarpine iontophoresis), or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.
* Age ≥ 14 years (changed from ≥ 18 years by protocol amendment).
* Able to expectorate sputum at screening.
* History of persistent positivity for P. aeruginosa on respiratory culture (at least three positive oropharyngeal (OP), sputum and/or bronchoscopy cultures in the 24 months prior to screening).
* Able to reproducibly perform pulmonary function testing.
* Clinically stable at screening, with no evidence of pulmonary exacerbation.
* Written informed consent provided.
Exclusion Criteria:
* Sputum culture negative for P. aeruginosa or density less than 10E5 CFU/gm at screening.
* Sputum culture positive for B. cepacia at screening.
* Presence of P. aeruginosa in sputum with off-scale resistance to all antibiotics by either method of susceptibility testing at screening. (changed from multiply-resistant P. aeruginosa by protocol amendment)
* History of B. cepacia positive respiratory culture within 24 months prior to screening.
* Hospitalization or treatment for a pulmonary exacerbation within 2 months prior to screening.
* Administration of parenteral anti-pseudomonal antibiotics within 2 months prior to screening.
* Treatment with oral or inhaled anti-pseudomonal antibiotics, or azithromycin or other macrolides within 14 days prior to screening.
* History of allergy (urticarial rash, diffuse erythroderma, serum sickness) to more than two groups of antibiotics (aminoglycosides, penicillins, cephalosporins, monobactams, macrolides, or quinolones) that are a therapeutic option.
* History of anaphylaxis or other life threatening complication to any antibiotic in the six groups that are a therapeutic option.
* History of abnormal renal function (serum creatinine \> 1.5 x upper limit of normal) within one year of enrollment.
* History of abnormal liver function tests (\> 2.5 x upper limit of normal) within one year of enrollment.
* Clinically documented hearing loss that precludes treatment with aminoglycosides.
* Post lung transplantation.
* Positive pregnancy test or female who is lactating or is not practicing an acceptable method of birth control.
* Presence of a condition or abnormality that in the opinion of an investigator would compromise the safety of the patient or the quality of the data.
* Administration of any investigational agent within 30 days prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00153634
Study Brief:
Protocol Section:
NCT00153634