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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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