N/A
N=3,181
Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection
Tracheitis · Tracheobronchitis · Bronchitis · Chronic Bronchitis · Community-acquired Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT01108185 ↗Enrolled (actual)
3,181
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Compliance (Was the Dosage Followed - Yes, no) — 3154; 12; 15; 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance (Was the Dosage Followed - Yes, no) |
3154; 12; 15; 2; 1; 12 | — |
| PRIMARY The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events |
7; 0; 0 | — |
| SECONDARY Body Temperature |
1; 98; 1 | — |
| SECONDARY Body Temperature |
1; 98; 1 | — |
| SECONDARY Cough and Its Character |
164; 178; 2828; 11 | — |
| SECONDARY Cough and Its Character |
164; 178; 2828; 11 | — |
| SECONDARY Dyspnoea |
12; 27; 3128; 14 | — |
| SECONDARY Dyspnoea |
12; 27; 3128; 14 | — |
| SECONDARY Auscultation |
3115; 36; 15; 15 | — |
| SECONDARY Auscultation |
3115; 36; 15; 15 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01108185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.