Local Antibiotic Delivery for Community Acquired Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
- 主要终点
- DAOH14
研究概览
简要总结
This trial aims to determine whether treatment with inhaled levofloxacin (an antibiotic) is equal to systemic antibiotic treatment (usual care) for patients admitted to a hospital with community-acquired pneumonia in regards to treatment-effect and safety parameters.
Additionally, this study will assess if treatment with inhaled antibiotics leads to fewer antibiotic side-effects and a more preserved gastro-intestinal microbial environment.
The main question this study aims to answer is:
Does inhaled levofloxacin 240mg twice daily result in comparable days alive and out of hospital at 14 days compared to standard-of-care (usual care) antibiotic treatment for community-acquired pneumonia in admitted patients?
Secondary questions this study aims to answer are:
- Does treatment with inhaled levofloxacin reduce proportion of patients with antibiotic side-effects?
- Does treatment with inhaled levofloxacin lead to preserved diversity in the gut microbiome?
- Is treatment with inhaled levofloxacin comparable with usual care in regards to patient reported outcomes?
The above list is not the complete list of questions this study aims to answer, but serves as highlights.
详细描述
Community-acquired pneumonia is common and potentially fatal. Standard-of-care treatment mainly consists of systemic antibiotics and treatment supporting recovery (e.g. oxygen-therapy, fluid rescucitation, respiratory physiotherapy, sufficient dietary intake etc.). As with all medicinal treatments, antibiotic treatment is hard on the body and can lead to side-effects as well as organ-failure in extreme cases.
Antibiotic treatment naturally promotes antimicrobial resistance (AMR), which result in less effective antibiotic treatment, and ultimately it could potentially lead to antibiotics being rendered useless in treating infections such as pneumonia.
A strategy to reduce the promotion of antimicrobial restistance (AMR) is better targeting of the disease-inducing microbes and several other strategies exists. Physicians and researchers usually categorize the targeting of disease-promoting microbes as either "local"/"topical" or "systemic". No "local" treatment of community-acquired pneumonia has been demonstrated to this day, but "local" treatment is theoretically possible with inhaled antibiotics. This treatment strategy has been hypothesized in the last decade, but no studies have been conducted regarding community-acquired pneumonia.
This study will include 460 patients and be conducted in two stages: Stage A and Stage B, each stage including 230 patients.
Patients are included voluntarilty and with prior written informed consent.
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
- •Hospital admission within 24 hours.
- •Clinical suspicion of community-acquired pneumonia necessitating antibiotic treatment.
- •Defined as one or more of the following:
- •Chest X-ray, CT or ultrasound findings consistent with bacterial pneumonia*
- •Symptoms consistent with bacterial pneumonia (such as dyspnea, tachypnea, cough or purulent sputum)
- •C-reactive protein >50 mg/L OR central body temperature >38.0 °C OR blood leukocytes ≥10.0×109/L (1-3 of these fulfilled).
- •Age ≥ 18 years.
- •Able to give informed consent.
排除标准
- •Suspected septic shock defined as MAP < 65 mmHg on sequential measurements despite adequate volume resuscitation.
- •Oxygen requirement >4L/min to maintain acceptable peripheral oxygen saturation*.
- •Significant suspicion of an infection with a focus other than the lungs
- •Contraindications for fluoroquinolone treatment, including but not limited to:
- •Known allergy to fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone.
- •Medical history of myasthenia gravis.
- •Reduced kidney function (eGFR < 20 mL/min/1.73 m²).
- •Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.
- •Suspicion of clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).
- •Pregnancy**.
研究组 & 干预措施
Standard-of-care (Control)
Systemic antibiotic treatment
干预措施: Standard-of-care / Usual care (Drug)
Inhaled levofloxacin
干预措施: Inhaled levofloxacin (Drug)
结局指标
主要结局
DAOH14
时间窗: From inclusion to 14 days after
Days alive and out of hospital day 14
次要结局
未报告次要终点