Early Bactericidal Activity of Standard Drugs Used to Treat Mycobacterium Avium Complex: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Mycobacterium avium colony count in sputum
研究概览
简要总结
To assess the early bactericidal activity of Azithromycin 250mg by mouth daily over the first 14 days of treatment for Mycobacterium avium complex (MAC) lung disease.
详细描述
This research is being done to better understand several important aspects of treatment of Mycobacterium avium complex (MAC) lung infections using an early bactericidal activity (EBA) study design. MAC is an environmental bacteria that can cause chronic lung infection. Early bactericidal activity is the amount of bacterial killing that occurs during the first few weeks of antibiotic treatment. By collecting information about the EBA of azithromycin for MAC, the investigators will quantify the efficacy of azithromycin against pulmonary MAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Isolation of M. avium intracellulare complex from a respiratory specimen in the preceding 6 months
- •Fulfill American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) criteria for MAC lung disease
- •Intention by the treating clinician to treat for MAC lung disease.
- •Ability to produce a sputum sample of at least 10mL in a 16 hour period
- •Signed informed consent by the subject
排除标准
- •Prior treatment for pulmonary MAC within the past 6 months
- •Pregnancy
- •HIV with a cluster of differentiation 4 (CD4) <350
- •History of solid organ or hematologic transplant
- •Contraindication to azithromycin
- •Has any other condition that, in the opinion of the PI, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
研究组 & 干预措施
14 Day Azithromycin Monotherapy
For the first 14 days of therapy, participants will receive Azithromycin 250mg by mouth (PO) daily as monotherapy. Beyond day 14, all participants will receive guideline-based standard multi-drug therapy for Mycobacterium avium lung disease, as dictated by the physicians treating the participants.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Change in Mycobacterium avium colony count in sputum
时间窗: Baseline and Day 14
The early bactericidal activity of azithromycin for Mycobacterium avium will be determined as the change in Mycobacterium avium colony count (log10 colony forming unit (CFU) per mL) in sputum between baseline and day 14.
Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT)
时间窗: Baseline and Day 14
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between Baseline and Day 14.
Mean Change in Mycobacterium Avium Colony Count in Sputum
时间窗: Day 0 and Day 15
The early bactericidal activity of azithromycin for Mycobacterium avium will be determined as the change in Mycobacterium avium colony count (log10 colony forming unit (CFU) per mL) in sputum between baseline and day 15.
Mean Change in Time to Positivity of Mycobacterium Avium Growth in the Mycobacterial Growth Indicator Tube (MGIT)
时间窗: Day 0 and Day 15
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and day 15.
次要结局
- Change in Mycobacterium avium colony count in sputum(Baseline and 2 Months)
- Change in time to positivity of Mycobacterium avium growth in MGIT(Baseline and 2 Months)
- Estimation of plasma azithromycin area-under-the-curve (AUC) following oral dosing azithromycin(Pre-dose, 2, 4 and 6 hours post-dose on day 15, and 2 and 6 hours post-dose on day 29)
- Estimation of maximum plasma concentration (Cmax) of azithromycin(2 and 6 hours post-dose on day 29)
- Mean Change in Mycobacterium Avium Colony Count in Sputum(Day 0 and Day 8)
- Mean Change in Mycobacterium Avium Colony Count in Sputum(Day 8 to Day 15)
- Mean Change in Mycobacterium Avium Colony Count in Sputum(Day 0 and 2 Months)
- Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT(Day 0 and Day 8)
- Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT(Day 7 and Day 14)
- Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT(Baseline and 2 Months)
- Estimation of Plasma Azithromycin Area-under-the-curve (AUC) Following Oral Dosing Azithromycin(Pre-dose, 2, 4 and 6 hours post-dose on day 15 (range: 11-19 days))
- Estimation of Plasma Azithromycin Area-under-the-curve (AUC) Following Oral Dosing Azithromycin(2 and 6 hours post-dose on day 29 (range: 25-31 days))
- Estimation of Maximum Plasma Concentration (Cmax) of Azithromycin(Pre-dose, 2, 4 and 6 hours post-dose on day 15 (range: 11-19 days))
- Estimation of Maximum Plasma Concentration (Cmax) of Azithromycin(2 and 6 hours post-dose on day 29 (range: 25-31 days))
- Change in Mycobacterium avium colony count in sputum(Baseline and Day 7)
- Change in Mycobacterium avium colony count in sputum(Day 7 to Day 14)
- Change in time to positivity of Mycobacterium avium growth in MGIT(Baseline and Day 7)
- Change in time to positivity of Mycobacterium avium growth in MGIT(Day 7 and Day 14)
- Estimation of maximum plasma concentration (Cmax) of azithromycin(Pre-dose, 2, 4 and 6 hours post-dose on day 15)