TRI-STAR: Initial and Chronic MRSA Infection in CF (TRanslational Investigation of STaph. Aureus Resistance)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Changes in presence of hypermutable MRSA isolates post-therapy compared to pre-therapy.
研究概览
简要总结
This study aims to examine features of MRSA that are associated with chronic MRSA infection and bacterial persistence despite IV antibiotic therapy. Subjects are asked to expectorate sputum and complete CF symptom diaries both at beginning and end of IV therapy.
详细描述
This is an observational, translational study examined bacterial morphology and function pre- vs. post antibiotic therapy in patients with CF who experience a pulmonary exacerbation that requires IV antibiotics.
All clinical care is dictated by the treating physician(s).
Inclusion criteria:
-
Male or female with a confirmed diagnosis of CF (by sweat test and/or identification of 2 CF disease causing mutations).
-
Chronic infection with MRSA defined as having had MRSA positive respiratory cultures for > 1 year with > 50% of cultures being MRSA positive.
-
Being able to expectorate sputum on a consistent basis, i.e. also at the end of IV therapy 3A: starting April 2017 people with CF who cannot expectorate sputum can also participate if they will do two orapharyngeal swab cultures.
-
Having a pulmonary exacerbation defined for this protocol as the decision of the treating physician to start IV therapy in hospital or at home. Typically this occurs when there has been a >5% drop in FEV1 % predicted compared to the patient's baseline and increased respiratory symptoms.
-
NOTE: Patients who had oral or inhaled antibiotics with or without MRSA activity but failed i.e. are changed to IV antibiotics are allowed to participate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with a confirmed diagnosis of CF (clinical features and positive sweat test and/or identification of 2 CF disease causing mutations).
- •At least 4 years of age or older.
- •Chronic infection with MRSA defined as having had MRSA positive respiratory cultures for > 1 year with ≥ 50% of cultures being MRSA positive e.g. 2/4 of the most recent cultures grew MRSA.
- •Being able to expectorate sputum on a consistent basis, i.e. also at the end of IV therapy.
- •Having a pulmonary exacerbation defined for this protocol as the decision of the treating physician to start IV therapy in hospital or at home. Typically this occurs when there has been a >5% drop in FEV1 % predicted compared to the patient's baseline and increased respiratory symptoms.
- •NOTE: Patients who had oral or inhaled antibiotics with or without MRSA activity but failed this outpatient therapy i.e. are changed to IV anti-MRSA antibiotics are allowed to participate.(Example: was on oral doxycycline and on admission changed to ceftaroline = eligible. On oral doxycycline that is continued on admission = not eligible).
- •Patient enrollment should be prioritized to those receiving IV vancomycin or ceftaroline, with secondary consideration of patients who receive oral anti-MRSA therapy (TMP-SMX or a tetracycline derivative) that was initiated on hospital admission.
- •Patients on linezolid will not be included as this medication is given orally and IV and may confound analyses.
排除标准
- •Presence / infection with B. cepacia genomovar III (=B. cenocepacia). Subjects who have undergone lung or liver transplant in the past (NOTE: patients listed for transplant are eligible)
- •Concomitant participation and/or use of an investigational drug within 30 days of this study.
- •Concomitant observational studies are allowed with TRI-STAR, if approved by the other study investigator or their proxy.
结局指标
主要结局
Changes in presence of hypermutable MRSA isolates post-therapy compared to pre-therapy.
时间窗: 2-3 weeks (course of IV antibiotics as determined by clinician)
次要结局
- Other MRSA characteristics in sputum(2 weeks (course of IV antibiotics))
- Clinical improvement with therapy(2-3 weeks (course of IV antibiotics))