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Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia (LANDCAP 2)

2026年9月25日 更新者：Copenhagen Respiratory Research

Local Antibiotic Delivery for Community Acquired Pneumonia

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:

  1. Does treatment with inhaled levofloxacin reduce proportion of patients with antibiotic side-effects?
  2. Does treatment with inhaled levofloxacin lead to preserved diversity in the gut microbiome?
  3. 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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

Patients included in stage A will be treated with systemic antibiotics for 24 hours and will then be randomized to further treatment with either inhaled levofloxacin 240mg twice daily or continue the "usual care"-treatment that they were receiving. The duration of intervention is up to 5 days.

At 230 included patients a planned interrim analysis will be conducted by an appointed data safety monitoring board of certified healthcare professionals to assess the further continuation of the trial. If favorable assessment, the trial will commence to Stage B.

Patients included in Stage B will be randomized at admission to either usual standard-of-care treatment for 5 days OR inhaled levofloxacin 240mg twice daily for 5 days.

The trial is open-label, which means that both patients and healthcare professionals will know which treatment arm the patient is receiving.

研究类型

介入性

注册 (估计的)

460

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Hospital admission within 24 hours.

  2. 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)

  3. 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).

  4. Age ≥ 18 years.

  5. Able to give informed consent.

Exclusion Criteria:

  1. Suspected septic shock defined as MAP < 65 mmHg on sequential measurements despite adequate volume resuscitation.

  2. Oxygen requirement >4L/min to maintain acceptable peripheral oxygen saturation*.

  3. Significant suspicion of an infection with a focus other than the lungs

  4. 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.

  5. Reduced kidney function (eGFR < 20 mL/min/1.73 m²).

  6. Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.

  7. Suspicion of clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).

  8. Pregnancy**.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Standard-of-care (Control)

Systemic antibiotic treatment
药品：Standard-of-care / Usual care

Standard-of-care / Usual care deemed of antibiotic treatment for community-acquired pneumonia assessed by the treating physician
实验性的：Inhaled levofloxacin
药品：Inhaled levofloxacin

Inhaled levofloxacin 240mg twice daily

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
DAOH14
大体时间：From inclusion to 14 days after

Days alive and out of hospital day 14
From inclusion to 14 days after

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Copenhagen Respiratory Research

调查人员

  • 研究主任：Jens-Ulrik S Jensen, Professor, PhD, Medical Doctor、Copenhagen Respiratory Research

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月28日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2026年9月21日

首先提交符合 QC 标准的

2026年9月21日

首次发布 (实际的)

2026年9月25日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2024-511420-13-00
  • 2024-511420-13-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All reasonable requests will be considered for pseudo-anonymized datasharing in accordance with applicable law of datasharing in the state of Denmark.

IPD 共享时间框架

At earliest 1 year after Last patients last visit.

IPD 共享访问标准

To be determined

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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