NL-OMON52868招募中3 期
Azole-echinocandin combination therapy for invasive aspergillosis. A randomized pragmatic superiority trial (IA-DUET) - IA-DUET/HOVON 502
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 325
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. 18 years or older
- •2. Have started or will start voriconazole or isavuconazole (or posaconazole if
- •voriconazole or isavuconazole cannot be given as per treating physician*s
- •decision) as antifungal therapy on the baseline visit.
- •3. For all patients: presence of one of the EORTC/MSG host factors or being
- •admitted to the ICU with influenza
- •4 For non-ICU patients or ICU patients without influenza: Meet the EORTC/MSG
- •clinical criterion.
- •5 For non-ICU patients or ICU patients without influenza: Meet the mycological
- •criterion or fulfil inclusion criterion 7.
- •6. For ICU patients with influenza we consider an isolated positive sputum
- •culture for Aspergillus spp. insufficient as a mycological criterion.
- •Therefore, in these patients only one of the following mycological criteria are
- •acceptable; Serum galactomannan >=0.5, BAL galactomannan >=1.0 or Aspergillus
- •spp. cultured in BAL fluid.
排除标准
- •1. Known history of allergy, hypersensitivity or serious reaction to triazole
- •or echinocandin antifungals;
- •2.Patients with chronic invasive aspergillosis or a chronic non-invasive
- •aspergillus infection (e.g. aspergilloma) defined as the clinical or
- •radiological sign of infection being present for >28 days.
- •3. Receipt of itraconazole, voriconazole, posaconazole as prophylaxis for at
- •least 7 days in the 14 days preceding the date of the first radiological signs
- •of the Aspergillus infection. Patients in which the most recent serum level of
- •the triazole given as prophylaxis was subtherapeutic can be included.
- •4. Receipt of echinocandin prophylaxis for >96 hours in the preceding 7 days
- •5 Receipt of systemic antifungal treatment with an echinocandin, a
- •triazole (except fluconazole) or amphotericin B for the current episode of
- •invasive aspergillosis for a duration of > 96 hours.
- •6.. For patients in the Netherlands only: Diagnostic testing to exclude
- •triazole resistance will not be possible (sputum cultures are negative and BAL
- •sampling will not be performed)
- •7. ICU patients only: Patients with a sequential organ failure assessment
- •(SOFA) score >11 at the time of screening for the study are excluded. If
- •randomization is done >24 hours after screening the calculation should be
- •repeated before the patient can be randomized (appendix 3)
- •8. ICU patients only: Patients in which weaning from the ventilator or ECMO
- •system is deemed unlikely due to irreversible lung damage
- •9. Patients with any condition which, in the opinion of the investigator, could
- •affect patient safety, preclude evaluation of response (e.g. because survival
- •beyond 6 weeks is unlikely due to the underlying disease status)
- •10. Patient previously included in this study
研究者
相似试验
进行中（未招募）
1 期
The IA-DUET study: A study on the usefulness of combination therapy for the treatment of an invasive fungal infection with Aspergillus.Invasive aspergillosisMedDRA version: 20.1Level: LLTClassification code 10022881Term: Invasive bronchopulmonary aspergillosisSystem Organ Class: 100000004862EUCTR2020-000627-40-BEErasmus MC650
进行中（未招募）
1 期
The IA-DUET study: A study on the usefulness of combination therapy for the treatment of an invasive fungal infection with Aspergillus.Invasive aspergillosisMedDRA version: 20.1Level: LLTClassification code 10022881Term: Invasive bronchopulmonary aspergillosisSystem Organ Class: 100000004862EUCTR2020-000627-40-NLErasmus MC650
终止
3 期
Azole-echinocandin Combination Therapy for Invasive AspergillosisInvasive AspergillosisNCT04876716Erasmus Medical Center66
已完成
不适用
inezolid for the Treatment of Suspected or Proven Gram-positive Infections: A Randomized, Open-label Trial Comparing Linezolid IV/PO and Teicoplanin IV or IM.-J18-L03-I38 Endocarditis, valve unspecifiedEndocarditis, valve unspecifiedI38J18L03PER-009-00PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
已完成
不适用
Combination therapy with azelnidipine or trichlormethiazide added on olmesartan in hypertensive patients with glucose intoleranceHypertension with glucose intoleranceJPRN-UMIN000003459Kanazawa Medical University Diabetes & Endocrinology40