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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT01075204
Eligibility Criteria:
Inclusion Criteria:
* Adults, equal to or more than 18 years years of age
* Patients with respiratory tract infections, including any of the following:
* Acute tracheitis, acute tracheobronchitis
* Acute sinusitis
* Chronic sinusitis
* Acute tonsillopharyngitis
* Acute bronchitis
* Mild community-acquired pneumonia
* Acute exacerbation of chronic bronchitis
Exclusion Criteria:
* Known hypersensitivity to or previously intolerant of macrolides.
* Illness severe enough to warrant hospitalization or parenteral therapy.
* Concomitant use of any of the following medications:
* Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
* Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
* Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir.
* Severe immunodeficiency and chronic disease conditions.
* Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).
* Mental condition rendering the subject unable to understand the nature of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01075204
Study Brief:
Protocol Section:
NCT01075204