CompletedNot Applicable

Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection

Slovakia3,181 participantsStarted 2010-03

Plain-language summary

The aim of this post-marketing observational study (PMOS) is to describe the relief of symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once daily in patients with lower respiratory tract infection or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men, women at least 18 years old * with acute tracheitis, * acute tracheobronchitis, * acute bronchitis, * mild community-acquired pneumonia or * acute exacerbation of chronic bronchitis Exclusion Criteria: * Patients with known hypersensitivity to macrolide antibiotics * Patients with documented renal impairment (creatinine clearance under 30 ml/min). * Patients with documented liver parenchyma impairment (AST, ALT and GMT \> 3x higher level in comparison with the norm) * Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine * Pregnancy * Breast feeding

What they're measuring

Compliance (Was the Dosage Followed - Yes, no)

Timeframe: Day 10 - 16

The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events

Timeframe: Day 0 through Days 10 - 16

Trial details

NCT IDNCT01108185

SponsorAbbott

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-07

Results submitted2011-07-26

View on ClinicalTrials.gov More Tracheitis trials