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临床试验/NCT05291468
NCT05291468进行中(未招募)不适用

PHENOtype Based Therapy With Antibiotics in SARcoidosis Patients With and Without Presence of Cutibacterium Acnes in Granulomatous Tissue

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月15日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
SUVmax

研究概览

简要总结

In this study it is investigated whether treatment with azithromycin in combination with doxycycline reduces the bacterial load of C. acnes in granulomatous tissue of patients with sarcoidosis and subsequently decreases the inflammatory activation measured by FDG uptake and serum biomarkers.

详细描述

Sarcoidosis is a multisystemic disease with unknown origin mostly affecting intrathoracic lymph nodes, lungs and skin. Sarcoidosis is characterized by the formation of non-caseating granulomas causing a variety of symptoms based on the organs involved. Although frequently described as a benign disease, mortality rate has been estimated to be around 11.0 per 1000 person-years in patients with sarcoidosis, with respiratory failure as the most common cause of death in the western world.

The main treatment indication in sarcoidosis is risk of organ failure. In the literature the need for systemic treatment varies between 20-70%. Since there is no curative treatment for sarcoidosis, treatment is focused on suppression of the inflammation. This is usually done with the use of immunosuppressive drugs, such as prednisone and/or methotrexate, and in patients with severe refractory disease infliximab. It is well known that treatment with immunosuppressive drugs is associated with burdensome side effects for patients and impaired quality of life.

Considerable research has been done on the possible role C. acnes in the pathogenesis of sarcoidosis. In a recent work of our own group it was shown that presence of C. acnes within granulomatous tissue can be detected in 41% of Dutch patients with sarcoidosis. Azithromycin has an inhibiting effect on several bacterial infections, such as C. acnes. Therefore, sarcoidosis patients with C. acnes in the granulomatous tissue might benefit from treatment with azithromycin. Given the fact that microbial resistance to azithromycin is relatively easy to develop, it is common practice to treat C. acnes with a combination of azithromycin and doxycycline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65+ years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy proven sarcoidosis.
  • No treatment indication for the sarcoidosis
  • Inflammatory activity according to FDG-PET scan at baseline
  • SUVmax above 3 in the lung and/or above 5 in mediastinum/hili

排除标准

  • Increased duration of QT interval (>440ms for men and >450ms for women) on ECG
  • Hearing deficits, as this is a possible side effect of azithromycin
  • Being pregnant or breastfeeding at time of inclusion

研究组 & 干预措施

C Acnes present in granulomatous tissue, treatment with antibiotics

Active Comparator

patients who are in this arm will receive azithromycin and doxycycline for 3 months

干预措施: FDG-PET/CT (Radiation)

C Acnes present in granulomatous tissue, treatment with placebo

Placebo Comparator

patients who are in this arm will receive placebo for 3 months

干预措施: FDG-PET/CT (Radiation)

C Acnes NOT present in granulomatous tissue, treatment with antibiotics

Active Comparator

patients who are in this arm will receive azithromycin and doxycycline for 3 months

干预措施: FDG-PET/CT (Radiation)

C. Acnes NOT present in granulomatous tissue, treatment with placebo

Placebo Comparator

patients who are in this arm will receive placebo for 3 months

干预措施: FDG-PET/CT (Radiation)

结局指标

主要结局

SUVmax

时间窗: 2 weeks

Difference of standarized uptake value (SUVmax) uptake after treatment with antibiotics between patients with and without C. acnes in their granuloma

次要结局

  • quality of life according to questionnaire(2 weeks)
  • lung function(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcel Veltkamp, MD,PhD

Pulmonologist, Principle Investigator, member of staff ILD Center of Excllence

St. Antonius Hospital

研究点 (1)

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