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Study aim
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Determination and comparison of the effect of short-term treatment with Levofloxacin and Azithromycin in bronchiectasis patients in the prevention of respiratory tract infections
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Design
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This is a randomized, double-blind, parallel-based and community-based clinical trial study conducted in Phase 3 on 82 patients with bronchiectasis diagnosis. Patients randomly divided into two groups receiving Azithromycin or Levofloxacin on basis of random numbers.
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Settings and conduct
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After approving the research proposal from medical school, the researcher will enter the patients who have criteria for entering the study after explaining the goals and conditions of the study and obtaining informed consent. In one group, Levofloxacin will receive 5 days a month, and in another group, patients will receive Azithromycin at a dose of 250 mg per day throughout the duration of study. Medications will be identified with codes A and B and will be in the same shape, and therefore the patient and assessing person (physician) will not know how patients allocated.
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Participants/Inclusion and exclusion criteria
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All patients with generalized bronchiectasis accompanied by septic mucus that have exacerbated disease more than 3 times in year
Entry criteria: having a definite diagnosis of bronchiectasis, satisfaction to participate in study
Exit criteria: having CF, allergies, asthma, tuberculosis
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Intervention groups
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Patients will be randomly divided into two equal groups after entering the study. In one group, Levofloxacin 500 mg will receive 5 days in month, and in another group, patients will receive Azithromycin 250 mg per day throughout the duration of study. Patients have been followed for one year and during this time, the number of admissions and number of exacerbations will be compared.
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Main outcome variables
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Average frequency of exacerbations of bronchiectasis, average admission rate, frequency of side effects