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

Abbott

Status: Completed

Conditions: Respiratory Tract Infection

Treatments: Drug: clarithromycin modified release 500 mg

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01075204

P11-989

Details and patient eligibility

About

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.

Enrollment: 335 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

335 participants in 1 patient group

Clarithromycin modified release

Description:

Patients with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.

Treatment:

Drug: clarithromycin modified release 500 mg