Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia: an Open, Controlled and Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 242
- 试验地点
- 8
- 主要终点
- Number of DOT
研究概览
简要总结
Background: Community-acquired pneumonia (CAP) continues to be a major health problem with significant mortality and it's one of the main causes of antibiotic prescription. Antibiotic overuse is a key driver of antimicrobial resistance and exposes patients to an increased risk of other antibiotic-related adverse events. The investigators aim to assess if rapid molecular tests are an effective tool to reduce antibiotic use in CAP compared to routine microbiological testing.
Design: Randomized, controlled, open-label clinical trial with two parallel groups (1:1) settled in a two-year multicenter, two tertiary care hospitals, between 2019 and 2021. Eligible participants will be non-severely immunosuppressed adult patients hospitalized for CAP through the emergency department. Primary endpoint will be antibiotic consumption measured by days of antibiotic therapy (DOT) per 1000 patient-days. Secondary end points will be: de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, antibiotic-related side effects, length of hospital stay, days until clinical stability, need for ICU admission, need for hospital readmission in the 30 days after randomization, death from any cause in the 30 days after randomization. Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) or standard diagnosis (only microbiological routine testing). A total of 220 patients are estimated in the experimental arm (undergoing comprehensive molecular testing) and 220 control subjects (undergoing routine testing) to be able to reject the null hypothesis that experimental and control groups have equal DOT per 1000 patients-days with a probability above 0.8.
Discussion: Comprehensive molecular tests could be a key tool in the optimization of etiological diagnostics in CAP and, therefore, a key element in antimicrobial stewardship programs developed to improve safety and antibiotic use in CAP.
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
- 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
- •Adult patients (18 years of age or older), of both sexes, hospitalized with a diagnosis of CAP in the first 24 hours of the admission.
- •Patient or his legal representative gives the informed consent
排除标准
- •Patient with acute infection by SARS-CoV-2 being this defined as:
- •Clinic of COVID-19 compatible, PCR positive for SARS-CoV-2 and negative serology for SARS-CoV-
- •COVID-19 clinic compatible, PCR positive for SARS-CoV-2 (in the last 60 days) and positive serology for SARS-CoV-
- •Pregnancy and / or nursing.
- •Severe immunocompromised patients (chemotherapy or radiotherapy in the previous 90 days, use of immunosuppressive drugs, chronic use of corticosteroids at a minimum dose of 15 mg / day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplant, patients with HIV and CD4 count ≤ 200 cells / mm3).
- •Imminent death (life expectancy ≤ 24 hours).
- •Participation in another clinical trial of pharmacological treatment during the previous 3 months.
结局指标
主要结局
Number of DOT
时间窗: Up to 30±5 days after hospital discharge
Number of days of antibiotic therapy
次要结局
- Number of days until de-escalation(Up to 30±5 days after hospital discharge)
- Number of days with intravenous antibiotic treatment.(Up to 30±5 days after hospital discharge)
- Rate of complicated community-acquired pneumonia (CAP)(Up to 30±5 days after hospital discharge)
- Rate of general complications(Up to 30±5 days after hospital discharge)
- Number of adverse events related to antimicrobials(Up to 30±5 days after hospital discharge)
- Number of participants with Clostridium difficile infection(Up to 30±5 days after hospital discharge)
- Phlebitis rate(Up to 30±5 days after hospital discharge)
- Number of days of non-invasive ventilation(Up to 30±5 days after hospital discharge)
- Number of days of hospital admission(Up to hospital discharge - a medium of 5 days)
- 30 day case-fatality rate(Up to 30±5 days after randomization)
- CAP-related fatality rate(Up to 30±5 days after hospital discharge)
- Rate of readmissions(Up to 30±5 days after hospital discharge)
- Number of adverse events(Up to 30±5 days after hospital discharge)
- All-cause fatality rate(Up to 30±5 days after hospital discharge)
- Number of days until antimicrobial monotherapy(Up to 30±5 days after hospital discharge)
- Number of days until etiological diagnosis(Up to 30±5 days after hospital discharge)
- Number of days of Oxygen treatment(Up to 30±5 days after hospital discharge)
- Early mortality rate(Up tp 5 days after randomization)
- Number of DOT per 1000 patients-day(Up to 30±5 days after hospital discharge)
研究者
Jordi Carratala
Head of Infectious Diseases
Hospital Universitari de Bellvitge