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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01076166
Eligibility Criteria:
Inclusion Criteria:
* Patients with lower respiratory tract infection.
* Patient is male or female \> 6 months and \< 12 years of age.
* Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
* Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information
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
* Ritonavir.
* Severe immunodeficiency and chronic disease conditions.
* Renal or hepatic impairment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Years
Study:
NCT01076166
Study Brief:
Protocol Section:
NCT01076166