Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborators: Eilaf; Eilaf CRO
• Treatments: Clarithromycin

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.