2022-502962-26-00招募中3 期
A RANDOMIZED PROSPECTIVE CLINICAL TRIAL TO ASSESS PROCALCITONIN-GUIDANCE AND MOLECULAR-GUIDED DIAGNOSIS AS MAINSTAY FOR THERAPY OF SEVERE INFECTIONS (The MODIFY trial)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 12
- 主要终点
- The number of days under treatment with broad-spectrum antibiotics in the group receiving the MODIFY strategy compared to patients treated by standard of care.
研究概览
简要总结
The main objective of the MODIFY trial is to decrease the number of days patients are treated with empirical broad-spectrum antibiotics.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •For women of child-bearing potential, willingness to avoid pregnancy during the study and agreement to notify investigator if pregnancy occurs.
- •Age more than or equal to 18 years
- •Sepsis defined by the Sepsis-3 definition; this is defined separately for community-acquired sepsis and for hospital-acquired sepsis. Community-acquired sepsis is defined as any SOFA score 2 points or more for patients admitted in hospital emergencies with community-acquired pneumonia (CAP), community-acquired acute pyelonephritis (AP) or community-acquired primary bacteremia (BSI). CAP, AP and BSI are considered community-acquired for patients who have no history of hospitalization lasting more than 2 days the last 90 days or who are not under hemodialysis or who are not residents of long-term care facilities. Hospital-acquired sepsis is defined as any SOFA score increase by 2 points or more from the admission SOFA score for patients with onset of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) or primary bacteremia (BSI) at least 48 hours after hospital admission. For patients with history of hospitalization lasting more than 2 days the last 90 days or who are under hemodialysis or who are residents of long-term care facilities and are admitted to hospital with HAP, VAP, AP and BSI the definition of hospital-acquired sepsis applies. In this case, the baseline SOFA score is considered as the known SOFA score before infection onset.
- •Presence of one of the following infections: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) and primary bacteremia (BSI).
- •Positive blood culture
- •Written informed consent provided by the patient or by their legal representative in case of patients unable to consent due to sepsis onset affecting their mental capacity.
- •Patients who have completed their participation in another study for more than 30 days can be included in this study.
排除标准
- •Failure to obtain written consent to participate
- •Previous enrollment in this study within the past 90 days. Patients enrolled in another study will not be accepted.
- •Patients in pregnancy or breastfeeding. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
- •Patients receiving prolonged antibiotic therapies (e.g. endocarditis, implantable device-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis)
- •Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
- •Patients with infection due to Mycobacterium tuberculosis
- •Patients suffering from cystic fibrosis
- •Severely immunocompromised patients such as a) patients with infection by the human immunodeficiency virus and with a CD4 count of less than 200 cells/mm3; b) neutropenic patients with less than 500 neutrophils/mm3; and c) patients with solid organ transplantation.
结局指标
主要结局
The number of days under treatment with broad-spectrum antibiotics in the group receiving the MODIFY strategy compared to patients treated by standard of care.
The number of days under treatment with broad-spectrum antibiotics in the group receiving the MODIFY strategy compared to patients treated by standard of care.
次要结局
- Time to first change of antibiotics
- Time to the first sterile blood culture
- Maintenance of the same antimicrobial(s) in case of activity against the pathogen
- At least 2-point decrease of baseline SOFA score by day 7
- 28-day mortality
- 90-day mortality
- Incidence of laboratory documented Clostrioides difficile infection
- Length of hospital stay
- Cost of hospitalization
- Time to escalation of antibiotics
- Time to de-escalation of antibiotics
研究者
President of the board
Scientific
Hellenic Institute For The Study Of Sepsis
研究点 (12)
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