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Study on Inhaled Levofloxacin for Treating Community-Acquired Pneumonia in Patients Without Systemic Antibiotics

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of community-acquired pneumonia, a type of lung infection that people can get outside of a hospital setting. The study is comparing two different treatments to see which is more effective. One treatment involves using an inhaled medication called levofloxacin, which is a type of antibiotic that helps fight bacteria in the lungs. The other treatment uses a combination of two antibiotics, piperacillin and tazobactam, which are given through an intravenous infusion, meaning they are delivered directly into the bloodstream through a vein.

The purpose of the study is to determine if the inhaled levofloxacin treatment is as effective as the intravenous piperacillin/tazobactam treatment in helping patients recover from pneumonia. Participants in the study will receive one of these treatments for 4 to 5 days. The study will monitor how many days patients are alive and out of the hospital within 14 days after starting treatment. This will help researchers understand which treatment allows patients to recover more quickly and safely.

Throughout the study, researchers will also look at other factors, such as any side effects from the antibiotics, changes in the diversity of bacteria in the gut, and overall health outcomes at 30 days. This information will help provide a clearer picture of the benefits and risks of each treatment option for community-acquired pneumonia.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Hospital admission
Upon joining the study, admission to the hospital occurs within 24 hours.
A new chest infiltrate, visible on a radiological exam, confirms pneumonia, accompanied by symptoms such as fever, cough, sputum, difficulty breathing, or chest pain.
Step 2
Initial treatment decision
The attending physician determines the necessity of treatment with intravenous piperacillin/tazobactam.
This decision is based on specific criteria, including a C-reactive protein level greater than 50 or a central body temperature exceeding 38.0°C.
Step 3
Treatment with inhaled levofloxacin
The treatment involves inhaling levofloxacin at a dose of 240 mg, administered twice daily.
This treatment continues for a duration of 4 to 5 days, without the use of systemic antibiotics.
Step 4
Monitoring and evaluation
The primary goal is to assess the number of days alive and out of the hospital within 14 days.
Secondary evaluations include the number of days alive and out of the hospital at 30 days, and without antibiotics, as well as the occurrence of any antibiotic-related side effects.
Step 5
Additional assessments
Further assessments involve changes in gut microbiome diversity and composition from stool and oral samples on day 5 and day 60.
Other measures include all-cause mortality at 30 days, and the proportion of patients readmitted, admitted to ICU, or deceased at 30 days.
Step 6
Patient-reported outcomes
Patient-reported outcomes are measured through changes in visual analogue scales for symptoms such as difficulty breathing, cough, and fatigue from day 1 to day 5.

Who can join the trial?

6 criteria

Must be admitted to the hospital within the last 24 hours.
Must have a new chest problem seen on an X-ray that looks like pneumonia, along with symptoms like fever, cough, producing mucus, difficulty breathing, and/or chest pain.
The doctor treating the patient has decided that the patient should receive a specific antibiotic treatment called **IV piperacillin/tazobactam**.
Must have a **C-reactive protein** level greater than 50, or a body temperature higher than 38.0°C. **C-reactive protein** is a substance in the blood that increases when there is inflammation or infection.
Must be 18 years of age or older.
Must be able to understand the study and agree to participate by giving informed consent.

Who cannot join the trial?

7 criteria

Patients who are currently taking other antibiotics that are not part of the study.
Patients with a history of allergic reactions to the study medications.
Patients with severe liver or kidney problems.
Patients who are pregnant or breastfeeding.
Patients with other serious health conditions that might interfere with the study.
Patients who have participated in another clinical trial recently.
Patients who are unable to follow the study procedures or take the study medication as directed.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Bispebjerg Hospital
Copenhagen, Denmark
Verified
Herlev Hospital
Herlev, Denmark
Verified
Hillerod Hospital
Hillerød, Denmark

Trial locations

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Investigated drugs

Levofloxacin
is an antibiotic used to treat infections. In this trial, it is given through inhalation to help treat community-acquired pneumonia. The goal is to see if using inhaled levofloxacin alone, without other antibiotics, is as effective as other treatments in helping patients recover and stay out of the hospital.
Piperacillin/Tazobactam
is a combination of two antibiotics used to treat a variety of infections. In this trial, it is given intravenously, meaning it is administered directly into the bloodstream. The trial aims to compare the effectiveness of this treatment with inhaled levofloxacin in treating community-acquired pneumonia.

Levofloxacin

What is already known about the treatment

Levofloxacin
This medication is administered through inhalation, typically in a dosage of 240 mg twice daily. It is currently being studied in clinical trials for its effectiveness in treating community-acquired pneumonia without the use of systemic antibiotics. Levofloxacin is primarily used to treat bacterial infections by inhibiting bacterial DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication and cell division. It belongs to the pharmacological class of fluoroquinolone antibiotics.
Piperacillin/Tazobactam
This medication is administered intravenously and is commonly used in hospitals to treat severe bacterial infections. It is being compared in clinical trials to inhaled levofloxacin for the treatment of community-acquired pneumonia. Piperacillin is a penicillin antibiotic that works by interfering with the formation of bacterial cell walls, while tazobactam is a beta-lactamase inhibitor that enhances the effectiveness of piperacillin by preventing bacterial resistance. This combination is classified as a penicillin antibiotic with a beta-lactamase inhibitor.

Investigated diseases

Community-acquired pneumonia – This is an infection of the lungs that occurs in individuals who have not recently been hospitalized. It is typically caused by bacteria, viruses, or fungi that are inhaled into the lungs. The disease often begins with symptoms such as cough, fever, and difficulty breathing. As it progresses, patients may experience chest pain, fatigue, and a worsening cough that produces phlegm. In severe cases, it can lead to complications like fluid accumulation in the lungs or difficulty in oxygen exchange. The progression and severity can vary based on the individual's age, overall health, and the specific pathogen causing the infection.