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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clarithromycin modified release

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.

clarithromycin modified release 500 mg

Intervention Type DRUG

clarithromycin modified release 500 mg for 7 days

Interventions

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clarithromycin modified release 500 mg

clarithromycin modified release 500 mg for 7 days

Intervention Type DRUG

Other Intervention Names

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Clarithromycin Modified Release 500 mg (Klacid XL)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No