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 (KLARAINE)

Abbott

Status: Completed

Conditions: Respiratory Tract Infections

Treatments: Drug: Clarithromycin (Klacid SR)

Study type: Observational

Funder types: Industry

Identifiers

NCT01095978

P11-979

Details and patient eligibility

About

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.

Full description

The postmarketing observational study is observational in nature. Its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. Follow-up of patients should enable two patient visits during this period.

The screening/inclusion visit (Visit 1) will be performed when the decision for Klacid SR therapy in a daily dose of 1000 mg is made. The second visit of the patient will occur 10 - 16 days from the screening/inclusion Visit (upon physician's decision). The physician can change the numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Enrollment: 2,822 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men, women 18 years with

  1. Acute tracheitis.
  2. Acute tracheobronchitis.
  3. Acute bronchitis.
  4. Mild community-acquired pneumonia.
  5. 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

Trial design

2,822 participants in 1 patient group

Acute upper respiratory tract diseases, bronchitis, pneumonia

Treatment:

Drug: Clarithromycin (Klacid SR)