PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Response rate according to 18F-FDG-PET/CT (PET/CT response)
研究概览
简要总结
OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary aspergillosis (IPA) could occur earlier than that of conventional imaging.
This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6. The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.
详细描述
Invasive pulmonary aspergillosis (IPA) is the 3rd most frequent invasive mycosis in France with a rising incidence and 40% mortality (Bitar, 2014, Lortholary, 2011). Modern antifungals (AF) improved survival of IPA but lead to ecological, toxic and cost issues. In agreement with the " plan national de la bonne maîtrise des anti-infectieux ", optimization of AF duration in IPA appears therefore challenging.
Positron emission tomography using 2-deoxy-2-[fluorine-18] fluoro- D-glucose integrated with computed tomography (18F-FDG PET/CT) was reported to allow shortened AF duration (Hot, 2011, Chamilos, 2008) and is currently evaluated during chronic disseminated candidiasis {CANHPARI trial, PHRC 2012, NCT01916057}. The investigators raise the hypothesis that normalization of the functional imaging 18F-FDG-PET/CT during IPA could occur earlier than that of conventional imaging. However, due to the current lack of data, an intervention trial evaluating an early AF withdrawal based on 18F-FDG-PET/CT appears premature. In order to optimize IPA treatment duration, a two-step evaluation project has been designed. The first step consists in OPTIFIL prospective project. It will evaluate the therapeutic response through a systematic 18F-FDG-PET/CT at week 6 (crucial time point (Segal) used in recent IPA trials (Marr, 2015, Maertens, 2016). The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12. OPTIFIL project results will serve establishing a decision algorithm used during the second step intervention trial evaluating the accuracy of IPA AF interruption.
Pilot prospective multicenter study of therapeutic follow-up of IPA in patients with hematological malignancy.
Patients will have an inclusion visit (D0) and 8 or 9 follow up visits: D3, W1, W2, W4, W6, End of Treatment, W24 and W48.
Each visit will include physical examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years-old
- •Patient with hematological malignancy
- •Proven or probable invasive pulmonary aspergillosis according to EORTC/MSG modified criteria
- •Inclusion ≤ 4 days (≤ 5 days in case of week end) after IPA diagnosis
- •Possibility to perform 18F-FDG-PET/CT scanner within the 7 subsequent days following diagnosis
- •Informed consent form signed
- •Affiliation to French social insurance
排除标准
- •Pregnancy or breastfeeding women
- •Life expectancy < 3 months
- •Fungal or mycobacterial lung co infection at time of IPA diagnosis
- •Haematological malignancy with lung location
- •Proven or probable mold infection in 6 previous months
- •Disseminated aspergillosis (lung and sinus aspergillosis can be included)
研究组 & 干预措施
Patient with invasive pulmonary aspergillosis
Blood collection and imaging 18F-FDG-PET/CT
干预措施: imaging 18F-FDG-PET/CT (Device)
Patient with invasive pulmonary aspergillosis
Blood collection and imaging 18F-FDG-PET/CT
干预措施: Blood collection (Biological)
结局指标
主要结局
Response rate according to 18F-FDG-PET/CT (PET/CT response)
时间窗: 6 weeks
次要结局
- Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions(12 weeks)
- Response rate according to EORTC/MSG criteria (Segal response).(12 weeks)
- Patient mortality rate(48 weeks)
- Response rate according to PET/CT(12 weeks or at the end of treatment)
- Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions in initial work-up(first day)