Study of Trimodulin for Adults Hospitalized with Severe Community-Acquired Pneumonia

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What is this study about?

This clinical trial is focused on studying a condition known as severe community-acquired pneumonia, which is a serious lung infection that people can get outside of a hospital setting. The study is testing a treatment called Trimodulin, which is a solution made from human proteins that help the immune system. This treatment will be compared to a placebo, which looks like the treatment but does not contain the active ingredients. Both Trimodulin and the placebo will be given to patients through an intravenous infusion, meaning they will be administered directly into the bloodstream through a vein.

The purpose of the study is to see if Trimodulin can reduce the number of deaths within 28 days compared to the placebo. Participants in the study are adults who are hospitalized with severe pneumonia. The study will follow these patients over a period of time to monitor their health and recovery. Researchers will look at various outcomes, such as how many patients survive, how their health changes over time, and how long they need to stay in the hospital or intensive care unit.

Throughout the study, doctors will also check for any side effects or reactions to the treatment. The study aims to provide valuable information on whether Trimodulin is a safe and effective treatment for severe pneumonia, potentially offering a new option for patients with this serious condition.

1 joining the study

Upon joining the study, written informed consent is required. This means agreeing to participate after understanding the study details.

Eligibility is confirmed based on criteria such as being an adult hospitalized with severe pneumonia and having certain medical indicators.

2 initial assessment

An initial assessment is conducted to confirm the diagnosis of severe community-acquired pneumonia. This includes reviewing medical history and conducting necessary tests.

Radiological evidence, such as X-rays, is used to confirm active pneumonia.

3 treatment initiation

Treatment with the investigational medication, trimodulin, or a placebo begins within 24 hours after starting mechanical ventilation.

The medication is administered as an intravenous infusion, which means it is given directly into a vein.

4 treatment duration

The treatment continues as per the study protocol, with regular monitoring of health status and response to the medication.

The duration of the treatment and frequency of administration are determined by the study guidelines.

5 monitoring and follow-up

Throughout the study, health is closely monitored. This includes checking vital signs, conducting laboratory tests, and assessing overall well-being.

Regular follow-ups are scheduled to track progress and any changes in health status.

6 completion of study

The study concludes after a specified period, with a final assessment to evaluate the effectiveness and safety of the treatment.

Participants may be asked to return for additional follow-up visits to monitor long-term outcomes.

Who Can Join the Study?

  • Written informed consent must be obtained from the subject or their legally authorized representative. This means you or someone legally allowed to make decisions for you must agree to participate after understanding the study.
  • You must be an adult, aged 18 years or older, and can be of any gender.
  • Your C-reactive protein (CRP) level must be 70 mg/L or higher within 24 hours before starting the study treatment. CRP is a substance in your blood that increases when there is inflammation in your body.
  • You must have been diagnosed with active community-acquired pneumonia (CAP) either before being admitted to the hospital or within 48 hours after admission. This is a type of lung infection you get outside of a hospital setting.
  • There must be radiological or other imaging evidence that shows you have active pneumonia. This means there should be images, like X-rays, that confirm the lung infection.
  • You must have acute respiratory failure that requires invasive mechanical ventilation (IMV). This means you need a machine to help you breathe because your lungs are not working well enough on their own.
  • The study treatment must be started between 1 and 24 hours after you begin receiving IMV.
  • You must be receiving standard care treatment for severe community-acquired pneumonia (sCAP) according to the guidelines that apply in your region and globally. This means you should be getting the usual treatment recommended for your condition.

Who Cannot Join the Study?

  • Patients with severe community-acquired pneumonia (sCAP) cannot participate if they have other serious health conditions that might interfere with the study.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of allergic reactions to the study medication or similar medications cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with certain medical conditions that the study doctors believe would make participation unsafe are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Medizinische Universitaet Innsbruck Innsbruck Austria
Groupe Hospitalier Du Sud Ile De France Melun France
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
University Hospital Galway Galway Ireland
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Centre Hospitalier Universitaire De Nice Nice France
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
Assistance Publique Hopitaux De Paris Paris France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre Hospitalier Victor Dupouy Argenteuil France
Hospital Clinic De Barcelona Barcelona Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Centre Hospitalier Universitaire De Rennes Rennes France
Ziekenhuis Oost Limburg Genk Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Nemocnice Kyjov prispevkova organizace Kyjov Czechia
Hospital Universitari Joan XXIII De Tarragona Tarragona Spain
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Virgen del Rocío University Hospital Sevilla Spain
Vrije Universiteit Brussel Jette Belgium
Servei De Salut De Les Illes Balears Palma Spain
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Assistance Publique Hopitaux De Paris Paris France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Hopital Nord Franche-Comte Belfort France
Beaumont Hospital Dublin Ireland
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Oblastni nemocnice Kolin a.s. nemocnice Stredoceskeho kraje Kolin Czechia
Chkirv Hptmeteabpx Usfhexllvtazd Rwnfi Reims France
Usecvekixdadwslqhqqwu Eicgz Azk Essen Germany
Irlgf Cvu Crmhglled Charleroi Belgium
Odjinkdsgwsdzfykodyerhxgod Aalst Belgium
Citnwznwd Utylqeesmlfplu Srgnsquhl Woluwe-Saint-Lambert Belgium
Pyxs Tyhcw Hwymgwyu Uccurlfkyhis Sabadell Spain
Haoyuvym Dz Lq Stznw Cuml I Ssjn Pyw Barcelona Spain
Ukaabbwswc Oo Acglqov Edegem Belgium
Aivaodxosd Pyyzshym Hotpyogp Dh Pnqsk Paris France
Sz Vdzleqlsdnczcdj Uwapavzazx Hwgedlrf Dublin Ireland
Hcskyueb Vhri datwmtui Barcelona Spain
Ictuohhc dp Cnnyrzsnudta Hjljlyrriyp Umujbgyylarpo dm Srjzs Eqjavyb (ihjmfnb Saint Priest En Jarez France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.05.2023
Belgium Belgium
Recruiting
01.05.2023
Czechia Czechia
Recruiting
01.05.2023
France France
Recruiting
01.05.2023
Germany Germany
Recruiting
01.05.2023
Hungary Hungary
Recruiting
01.05.2023
Ireland Ireland
Recruiting
01.05.2023
Romania Romania
Recruiting
01.05.2023
Spain Spain
Recruiting
01.05.2023

Trial locations

Trimodulin (BT588) is a medication being tested in this clinical trial. It is designed to help people who are hospitalized with severe community-acquired pneumonia, which is a serious lung infection. Trimodulin is a type of therapy that aims to support the immune system in fighting the infection. The goal of using trimodulin in this trial is to see if it can reduce the number of deaths within 28 days compared to those who do not receive it. This medication is being studied to determine if it is more effective than not using it at all in treating this severe condition.

Severe community-acquired pneumonia (sCAP) – Severe community-acquired pneumonia is a serious lung infection acquired outside of a hospital setting. It begins with symptoms such as cough, fever, chills, and difficulty breathing. As the disease progresses, patients may experience increased respiratory distress and require supplemental oxygen or mechanical ventilation. The infection can lead to inflammation and fluid accumulation in the lungs, impairing oxygen exchange. In severe cases, it can cause systemic effects, impacting other organs and leading to complications like sepsis. The progression of the disease can vary, with some individuals experiencing rapid deterioration.

Trial ID:
2022-501352-28-00
Protocol code:
996
Trial Phase:
Therapeutic confirmatory (Phase III)

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