N/A
Completed N=2,822
Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine
Source: ClinicalTrials.gov NCT01095978 ↗Enrolled (actual)
2,822
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Body Temperature — 183; 170; 13; 2617 Participants
Summary
To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid® sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.
This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format.
Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population, and indication as well as with local guidelines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Temperature |
183; 170; 13; 2617; 2434; 183 | — |
| PRIMARY Cough and Its Character |
118; 110; 8; 1813; 1702; 111 | — |
| PRIMARY Dyspnoea |
1821; 1753; 68; 2608; 2451; 157 | — |
| PRIMARY Auscultation Findings |
389; 378; 11; 2494; 2350; 144 | — |
| PRIMARY Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia |
1742; 1651; 91; 1058; 953; 105 | — |
| PRIMARY Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) |
2381; 2237; 144; 377; 327; 50 | — |
| PRIMARY Therapeutic Response |
2786; 2592; 194; 14; 12; 2 | — |
| SECONDARY Adverse Effects |
14; 0; 1; 0 | — |
| SECONDARY Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) |
2786; 14; 1; 13 | — |
| SECONDARY Termination of Treatment |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Men, women 18 years with
- Acute tracheitis.
- Acute tracheobronchitis.
- Acute bronchitis.
- Mild community-acquired pneumonia.
- Acute exacerbation of chronic bronchitis.
- To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.
Exclusion Criteria
- Known hypersensitivity to macrolide antibiotics
- Documented renal impairment (creatinine clearance under 30 ml/min)
- Concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine
- Pregnancy
- Breast feeding
Data sourced from ClinicalTrials.gov (NCT01095978). 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. Informational only — not medical advice.