Study on Gremubamab for Patients with Bronchiectasis and Chronic Pseudomonas Aeruginosa Infection

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Gremubamab on individuals with bronchiectasis and a chronic infection caused by a bacteria known as Pseudomonas aeruginosa. Bronchiectasis is a condition where the airways in the lungs become widened and scarred, leading to mucus build-up and frequent lung infections. The trial aims to evaluate how effective Gremubamab is in reducing the amount of Pseudomonas aeruginosa bacteria in the sputum, which is the mucus that is coughed up from the lungs, over a period of 12 weeks.

Participants in the study will receive either Gremubamab or a placebo, which is a substance with no active medication, through an intravenous infusion, meaning it is administered directly into the vein. The study will last for a total of 12 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The main goal is to see if Gremubamab can help reduce the bacterial burden in the lungs, potentially leading to fewer infections and improved lung function.

The trial is designed to gather important information about the potential benefits of Gremubamab for people with bronchiectasis and chronic Pseudomonas aeruginosa infection. By participating in this study, researchers hope to find a new way to manage this challenging condition and improve the quality of life for those affected. The study will follow a structured schedule, with assessments at various points to track progress and gather data on the treatment’s effectiveness.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, clinical diagnosis of bronchiectasis, and previous test results showing Pseudomonas aeruginosa in the airways.

Informed consent is required to participate in the study.

2 baseline assessment

A baseline assessment is conducted to collect initial data. This includes a sputum sample to confirm the presence of Pseudomonas aeruginosa.

3 treatment administration

The treatment involves the administration of gremubamab or a placebo.

The medication is given as a solution for infusion through an intravenous infusion.

4 follow-up assessments

Follow-up assessments occur at various intervals: Days 7, 14, 28, 56, 84, and 168.

These assessments monitor the bacterial burden in sputum and other health indicators.

5 primary endpoint evaluation

The primary endpoint is evaluated on Day 84 to assess the efficacy of gremubamab in reducing Pseudomonas aeruginosa in sputum.

6 secondary endpoint evaluation

Secondary endpoints are evaluated from baseline to various days, including Days 28, 56, 84, and 168, to gather additional data on treatment effects.

7 completion of the study

The study is estimated to conclude by August 30, 2024, after all assessments and data collection are completed.

Who Can Join the Study?

Must be between the ages of 18 and 85.
Have a clinical diagnosis of Bronchiectasis, which is a lung condition where the airways become widened and scarred.
Must be able to understand and agree to participate in the study by signing a consent form.
Have had a previous CT scan of the chest showing bronchiectasis in one or more parts of the lungs. A CT scan is a special type of X-ray that gives detailed pictures of the inside of the body.
Have had Pseudomonas aeruginosa, a type of bacteria, found in a sample from the lungs or airways at least once in the 24 months before the study starts.
Provide a sputum sample, which is mucus from the lungs, that tests positive for Pseudomonas aeruginosa at the screening visit and within 35 days before being randomly assigned to a study group.

Who Cannot Join the Study?

Patients who do not have bronchiectasis (a condition where the airways in the lungs are damaged and widened) and a chronic Pseudomonas aeruginosa infection (a long-lasting infection caused by a specific type of bacteria) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hospital Del Mar	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Ajuntament De L Hospitalet De Llobregat	L'hospitalet De Llobregat	Spain
Hnsurfbw Du Lv Sdsmh Chym I Seyn Pdr	Barcelona	Spain
Hflncpaj Uzfnykusrsuql Htyjkkdr Tnkkl y Pglktd Ixyqsrnj Cfoyyw dpzrhdglbnkqixuwr (xsip	Badalona	Spain
Hxwmrbwr Vage dzsarkth	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	03.07.2023

Trial locations

Investigated drugs:

Gremubamab

Gremubamab is a medication being studied for its potential to reduce the amount of Pseudomonas aeruginosa bacteria in the sputum of patients with bronchiectasis. This trial aims to see if Gremubamab can effectively lower the bacterial burden in the lungs, which could help improve symptoms and outcomes for patients with chronic lung infections.

Bronchiectasis – This is a chronic condition where the walls of the bronchi, the air passages in the lungs, become thickened from inflammation and infection. Over time, the airways lose their ability to clear out mucus, leading to frequent lung infections. Symptoms often include a persistent cough, production of large amounts of sputum, and shortness of breath. The disease can progress with repeated infections causing further damage to the airways. This can lead to a cycle of infection and inflammation, worsening lung function over time.

Chronic Pseudomonas aeruginosa infection – This is a long-term infection caused by the bacterium Pseudomonas aeruginosa, commonly affecting individuals with underlying lung conditions. The bacteria can form biofilms, making them resistant to the body’s immune response and difficult to eradicate. Symptoms may include persistent cough, production of greenish or yellowish sputum, and difficulty breathing. The infection can lead to chronic inflammation and damage to lung tissue. Over time, this can result in a decline in lung function and increased frequency of respiratory exacerbations.

Trial ID:

2022-502494-41-00

Protocol code:

1-023-22

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Gremubamab for Patients with Bronchiectasis and Chronic Pseudomonas Aeruginosa Infection

What is this study about?

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