Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)

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What is this study about?

This clinical trial is focused on studying a condition known as Acute Respiratory Distress Syndrome (ARDS), which can occur due to pneumonia or other infections. ARDS is a serious lung condition that makes it difficult to breathe. The study is testing a treatment called Recombinant Human Plasma Gelsolin, also known as rhu-pGSN, which is given through an intravenous infusion. This means the treatment is administered directly into the bloodstream through a vein. The trial will compare the effects of rhu-pGSN with a placebo, which is a substance with no active medication, to see if rhu-pGSN is safe and beneficial for patients with moderate-to-severe ARDS.

The purpose of the study is to evaluate how well rhu-pGSN works in combination with the standard care that patients with ARDS usually receive. Participants in the study will be randomly assigned to receive either rhu-pGSN or a placebo, along with their regular treatment. The study will monitor participants over a period of time to assess their recovery and any side effects they may experience. The main focus will be on the survival rate of participants and their need for respiratory support, such as ventilators, during the study period.

Throughout the study, researchers will collect information on how many days participants can breathe without the help of a ventilator and how long they stay in the hospital. The study will also look at the overall safety of rhu-pGSN by tracking any new or worsening health issues that occur. This research aims to provide valuable insights into whether rhu-pGSN can improve outcomes for patients suffering from ARDS due to infections like pneumonia.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Informed consent must be obtained from the patient or their legal representative.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of moderate-to-severe acute respiratory distress syndrome (ARDS) due to pneumonia or other infections.

3 randomization

The patient will be randomly assigned to receive either the recombinant human plasma gelsolin or a placebo (0.9% saline solution).

4 treatment administration

The assigned treatment will be administered through an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

5 monitoring and follow-up

The patient’s health will be closely monitored throughout the study. This includes tracking the number of days without the need for a ventilator, overall survival, and any side effects or adverse events.

6 end of treatment evaluation

At the end of the treatment period, the patient’s condition will be evaluated to assess the effectiveness and safety of the treatment.

7 final follow-up

A final follow-up will occur to gather data on the patient’s recovery and any long-term effects of the treatment.

Who Can Join the Study?

  • The patient must have an infection that led to Acute Respiratory Distress Syndrome (ARDS) within a week. ARDS is a serious lung condition that makes it hard to breathe. This must be confirmed by a doctor or a radiologist, and the findings should be recorded and saved.
  • The patient must have acute hypoxemic respiratory failure for 48 hours or less. This means they have trouble getting enough oxygen into their blood due to ARDS. They should be receiving help to breathe, such as being on a ventilator, using a mask that provides air pressure, or receiving a high flow of oxygen.
  • The patient must be 18 years or older.
  • The patient or their legal representative must give informed consent to participate in the study. This means they understand the study and agree to take part.
  • There must be clear evidence of an infection that caused ARDS within the 7 days before the ARDS diagnosis, as judged by the medical team.
  • During the study and for 4 days after the last treatment, for a total of 10 days:
    • Women who can have children must agree to avoid pregnancy by using two approved birth control methods or abstaining from sex.
    • Men with partners who can become pregnant must agree to use reliable birth control methods, like a vasectomy or abstinence, or ensure their partner uses an acceptable method.
    • All participants must agree not to donate sperm or eggs.

Who Cannot Join the Study?

  • Patients who do not have a primary diagnosis of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) due to pneumonia or other infections cannot participate. ARDS is a serious condition where the lungs cannot provide enough oxygen to the body’s organs.
  • Patients with a P/F ratio greater than 150 cannot participate. The P/F ratio is a measure of how well the lungs are working, specifically how much oxygen is in the blood compared to the amount of oxygen being given to the patient.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
  • Patients who do not belong to the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients, but the exact group is not detailed here.
  • Both male and female patients are eligible, so exclusion is not based on gender.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain disabilities, but the specific group is not detailed here.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Centre hospitalier universitaire de Liege Liege Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Elias University Emergency Hospital Bucharest Romania
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Tokuda Hospital Sofia Bulgaria
Hospital Universitario De Getafe Getafe Spain
Hospital Universitari Joan XXIII De Tarragona Tarragona Spain
Medisch Spectrum Twente Enschede The Netherlands
HUmani Charleroi Belgium
Szent Damjan Goeroegkatolikus Korhaz Kisvarda Hungary
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
University Teaching Hospital Markusovszky Szombathely Hungary
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Saarland University Hospital Homburg Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Salut Sant Joan De Reus Reus Spain
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Gelre Hospitals Zutphen The Netherlands
Spitalul Clinic Judetean Mures Targu Mures Romania
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Krajska nemocnice Liberec a.s. Liberec Czechia
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Szfvnbz Kdoefuheedlljnfftntad Siofok Hungary
Vzjkbizl Vkogumxky Cugjqsmt Fpewvt Kkemma Veszprem Hungary
Pvey Tvyva Heykgxri Uomxujdwjkks Sabadell Spain
Gzsbdnuynvumhysah Vertgzsvo Pvbj Afaeub Ehvjmysz Obtkyc Kuifwx Gyor Hungary
Kizjjfjb dod Ufeobcnrqwml Mytbbped Alj Munich Germany
Meyzuwgm Mwzrikh Awjeadt Pleven Bulgaria
Hxfgygcr Uoszcxuvwnehlv Sinvssaemz &holmqn Hvxoynf dr Hyifjismkob STRASBOURG, Alsace France
Caw Kewbqzu Bfkimpp Le Kremlin-Bicetre France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.11.2024
Bulgaria Bulgaria
Recruiting
01.11.2024
Czechia Czechia
Recruiting
01.11.2024
France France
Recruiting
01.11.2024
Germany Germany
Recruiting
01.11.2024
Hungary Hungary
Recruiting
01.11.2024
Italy Italy
Recruiting
01.11.2024
Romania Romania
Recruiting
01.11.2024
Spain Spain
Recruiting
01.11.2024
The Netherlands The Netherlands
Recruiting
01.11.2024

Trial locations

Recombinant Human Plasma Gelsolin (rhu-pGSN) is a medication being studied for its potential to help patients with moderate-to-severe acute respiratory distress syndrome (ARDS) caused by pneumonia or other infections. It is used in addition to the standard care that patients are already receiving. The goal of using this medication is to see if it can improve the condition of patients by reducing the severity of ARDS symptoms.

Acute Respiratory Distress Syndrome (ARDS) Due to Pneumonia or other Infections – ARDS is a severe lung condition that occurs when fluid builds up in the tiny, elastic air sacs in the lungs. This fluid prevents the lungs from filling with enough air, which means less oxygen reaches the bloodstream. It often develops in people who are already critically ill or have significant injuries. The condition progresses rapidly, usually within a few hours to a few days after the initial injury or infection. As ARDS progresses, breathing becomes increasingly difficult, and the patient may require mechanical ventilation. The severity of ARDS can vary, and it is often associated with pneumonia or other infections that cause inflammation in the lungs.

Trial ID:
2023-510109-16-00
Protocol code:
BTI-203
NCT ID:
NCT05947955
Trial Phase:
Therapeutic exploratory (Phase II)

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