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Study on Inhaled Levofloxacin and Sodium Chloride for Patients with Community-Acquired Pneumonia, Including Those with Pre-existing Lung Disease

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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 effects of a treatment for community-acquired pneumonia, a type of lung infection that people can get outside of a hospital setting. The study will use a medication called Quinsair, which contains the active ingredient levofloxacin. Levofloxacin is an antibiotic that helps fight bacterial infections. The trial will also use sodium chloride, commonly known as saline, which is used as a control treatment. Both medications are administered as a nebuliser solution, meaning they are inhaled as a mist into the lungs.

The purpose of this study is to determine if adding inhaled levofloxacin to the treatment plan for patients with community-acquired pneumonia, including those with pre-existing lung conditions, improves or worsens their health status. Participants will receive the treatment twice daily for three days. The study will monitor changes in the participants' health, such as breathing ability and infection levels, to assess the effectiveness of the treatment.

Throughout the study, participants will be observed for any changes in their condition, including symptoms like fever, cough, and difficulty breathing. The trial aims to gather information on how well the treatment works and its impact on patients' recovery from pneumonia. This information will help in understanding the potential benefits and risks of using inhaled levofloxacin for treating 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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as recent hospital admission, symptoms consistent with pneumonia, and age of 18 years or older.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health status. This includes measuring lung function and other vital signs.
Step 3
Medication administration
The study involves the administration of levofloxacin via inhalation. The dosage is 240 mg, taken twice daily for a duration of three days.
The medication is delivered using a nebuliser solution, which allows the drug to be inhaled directly into the lungs.
Step 4
Monitoring and evaluation
Throughout the study, health status is monitored to observe any changes in physiological or infectious conditions.
Primary evaluation includes checking for a significant drop in lung function one hour after the first inhalation or at discharge.
Step 5
Secondary assessments
Secondary assessments involve monitoring various health indicators such as C-reactive protein levels, respiratory frequency, and body temperature on day 4.
Patient-reported outcomes are also collected, focusing on changes in symptoms like dyspnoea, cough, and fatigue.
Step 6
Completion of study
The study concludes after the final assessments are completed, and all data is collected for analysis.

Who can join the trial?

6 criteria

Must be admitted to the hospital within the last 24 hours.
Must have a new chest X-ray showing signs of pneumonia, along with symptoms like fever, cough, producing mucus, difficulty breathing, and/or chest pain.
Must have a CURB-65 score between 3 and 5. This is a score used to assess the severity of pneumonia, based on factors like confusion, blood urea levels, breathing rate, blood pressure, and age.
Must have a C-reactive protein level greater than 50, or a central body temperature higher than 38.0 °C. C-reactive protein is a substance in the blood that increases when there is inflammation in the body.
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?

9 criteria

Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are pregnant or breastfeeding are not eligible to join the study.
Patients with a history of severe allergic reactions to levofloxacin or similar medications cannot take part.
Patients with severe kidney problems, which means their kidneys do not work well, are excluded.
Patients with a history of seizures, which are sudden, uncontrolled electrical disturbances in the brain, cannot participate.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Patients with a known history of certain heart problems, like a condition called "QT prolongation," which affects the heart's rhythm, are excluded.
Patients who have a known infection with a bacteria that is resistant to levofloxacin cannot join the study.
Patients who are unable to follow the study procedures or take the study medication as directed are not eligible.

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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
Responsive
Roskilde University
Roskilde, Denmark

Trial locations

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Investigated drugs

Levofloxacin: This medication is an antibiotic used to treat infections. In this study, it is given as an inhaled treatment to see if it helps improve the condition of patients with community-acquired pneumonia. The goal is to determine if using inhaled levofloxacin can make a difference in the health of patients, whether they have existing lung disease or not.

What is already known about the treatment

Levofloxacin – This medication is administered as an inhaled solution, typically given at a dose of 240 mg twice daily for three days. It is currently being studied in clinical trials for its effectiveness in treating community-acquired pneumonia, particularly in patients with or without pre-existing lung conditions. Levofloxacin is primarily used as an antibiotic to treat various bacterial infections. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication, transcription, repair, and recombination. This medication belongs to the pharmacological class of fluoroquinolone antibiotics.

Investigated diseases

Community-acquired pneumonia – This is an infection of the lungs that occurs in people who have not recently been hospitalized. It is caused by bacteria, viruses, or fungi that are acquired outside of a healthcare setting. The disease typically begins with symptoms such as cough, fever, and difficulty breathing. As it progresses, patients may experience chest pain, fatigue, and increased mucus production. The severity of symptoms can vary, with some individuals experiencing mild illness while others may have more severe respiratory issues. The progression of the disease depends on the individual's overall health and the specific pathogen causing the infection.