Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
NCT00001318
Actinomycetales Infections, Bacterial Infections
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT01097005
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
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Notify Me15 year–99 year
All sexes
Observational
Site Reference ID/Investigator# 36460, Aichi, Japan
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."
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During the treatment with clarithromycin, from 40 days to 1232 days
Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin
Time frame: When treatment with clarithromycin is discontinued, from 40 days to 1232 days
Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales ("Effective", "Ineffective", "Deterioration", "Impossible")
Time frame: 36 months
Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion
Mylan Inc.
Industry
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