All studies
AuthorisedTherapeutic exploratory (Phase II)Interventional

Local Antibiotic Delivery for Community Acquired Pneumonia (LANDCAP 2)

This research study is called LANDCAP 2 and it's trying to find better ways to treat adult patients who have pneumonia, a common lung infection caught outside of hospital. We are testing different types of antibiotics. One approach involves giving antibiotics directly into the lungs using a special device called a nebuliser, while another looks at a different combination of antibiotics given in the usual way. The main goal is to see if these new treatment methods can help people get better sooner, spend less time in hospital, and experience fewer side effects. We also want to understand how these treatments affect the body and reduce the need for other antibiotics. This is an early stage study (Phase II) to gather more information.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Gentofte Hospital
Enrolment target
460
Start
11 Jul 2024

What is this study about?

This study, called LANDCAP 2, is all about finding improved ways to treat community-acquired pneumonia. This is a common and sometimes serious lung infection that people catch in their everyday lives, outside of a hospital setting. When you have pneumonia, your lungs become inflamed, making it hard to breathe, and it can cause symptoms like coughing, fever, and tiredness.

Currently, antibiotics are the main treatment for pneumonia. However, researchers are always looking for ways to make these treatments more effective, reduce side effects, and help patients recover quicker. In this study, we are exploring two different approaches. One involves directly delivering a specific antibiotic (called Quinsair) deep into the lungs using a nebuliser – a device that turns liquid medicine into a fine mist you can breathe in. This method aims to get the medicine right where it's needed most. The other approach compares a standard antibiotic treatment (Piperacillin/Tazobactam) to see how well it works.

The main aim of this study is to see how many days people are alive and out of the hospital within two weeks of starting treatment. We also want to know if these treatments lead to fewer side effects, help the body's natural balance (like gut bacteria) recover, reduce the chances of needing more hospital care, and generally improve how patients feel. This research is important because it could lead to new and better ways to fight pneumonia, helping people get back to full health faster.

Key takeaways

  • Exploring new treatment options for pneumonia caught outside hospital.
  • Testing an antibiotic delivered directly into the lungs.
  • Aims to reduce hospital stay and improve recovery.
  • Looks at side effects and longer-term well-being.
  • Involves adults aged 18 and over with pneumonia.

Who may be eligible?

Generally, to take part in this study, you must be at least 18 years old. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to participate.

The study is specifically for people who have been diagnosed with community-acquired pneumonia. This means the lung infection was caught outside of a hospital environment.

There will be other detailed criteria that the study doctors will check to make sure the treatment is safe and suitable for you. These will involve looking at your current health, other medical conditions you might have, and any medications you are taking. Your doctor will discuss all these points with you carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you recently been diagnosed with pneumonia that you caught outside of hospital?
  3. Are you able to attend regular appointments for checks?
  4. Are you willing to potentially receive different antibiotic treatments?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the study treatments. This could be a special antibiotic delivered by breathing it in with a nebuliser, a different antibiotic given in the usual way, or a 'dummy' treatment (like saline solution) if you are in a comparison group. You would be in the hospital for some of the initial treatment and observation.

Throughout the study, you would have regular visits and assessments with the study team. These visits would involve checking your health, taking samples (like blood, or stool/mouth swabs to look at gut bacteria), and asking you questions about how you are feeling, including your breathing, cough, and tiredness. They might also check your blood pressure, temperature, and how much oxygen you need. You wouldn't be able to take certain other antibiotics while in the study. The total duration of active follow-up would be at least 60 days, with key assessments at 14 and 30 days.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new or different treatment for your pneumonia, which could potentially help you recover quicker or with fewer side effects. However, there's also a chance the new treatment might not work as well for you as current treatments, or you might experience side effects. The study team will carefully monitor your health throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Denmark

Common questions

What is community-acquired pneumonia?

It's a serious lung infection you catch in your everyday life, outside of a hospital.

What kind of treatments are being tested?

We're testing a new antibiotic delivered by breathing it in (nebuliser) and comparing it to other antibiotic treatments.

How long does the study last?

Your involvement in the study will be monitored for at least 60 days.

Will I get a 'dummy' treatment?

Some participants might receive a simple saline solution, like salty water, for comparison, alongside standard care.

Can I stop participating if I want to?

Yes, you can leave the study at any time, and it won't affect your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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