Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
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To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
Full description
Background: The revised 2007 American Thoracic Society/Infectious Diseases Society of America guidelines recommend a clarithromycin-based combination therapy for treatment of Mycobacterium avium complex (MAC) lung disease and stipulate approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient.
Objectives: To obtain data on the clinical outcome of clarithromycin-based regimens by conducting a nationwide prospective study mainly of MAC lung disease.
Methods: In accordance with the guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multi-drug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin -based regimen) until bacilli negative conversion on continual treatment for 1 year. Data were collected "pre-administration," "on the bacilli negative conversion," and "at 6 months after the end of treatment."
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Inclusion and exclusion criteria
Inclusion Criteria
- Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Exclusion Criteria
- Contraindications according to the package insert
- Patients with a history of hypersensitivity to any ingredient of Klaricid
- Patients who are receiving pimozide, ergot-containing products, or cisapride
- Patients who have AIDS (Acquired Immune Deficiency Syndrome)
Trial design
466 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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