#1 Clinical Trials Search in Europe

Study on Glutathione and Sodium Chloride for Preventing Heart Injury in Pneumonia Patients

3 1 1

What is this study about?

This clinical trial is focused on studying the prevention of myocardial injury, which is a type of heart damage, in patients who have pneumonia. The study will use a treatment called TAD® 600 mg/4 ml solution for injection, which contains the active substance glutathione. Glutathione is a chemical that may help protect the heart from damage. The trial will also involve the use of sodium chloride solution, which is commonly used in medical settings as a solvent or diluting agent.

The purpose of the study is to evaluate the effectiveness and safety of TAD® as an additional treatment to prevent heart damage in patients hospitalized with pneumonia. Participants in the study will receive the treatment intravenously, meaning it will be administered directly into a vein. The study will compare the effects of TAD® with those of a placebo to determine its potential benefits. The trial will be conducted over a period of several days, during which participants will be closely monitored for any changes in their heart health.

Throughout the study, various health assessments will be conducted to monitor the participants’ heart function and overall well-being. These assessments will include measuring levels of certain proteins in the blood that indicate heart health, as well as performing tests like electrocardiograms (ECGs) to check heart rhythm and function. The study aims to provide valuable information on whether TAD® can be a safe and effective option for preventing heart damage in patients with pneumonia.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age between 18 and 80 years, diagnosis of community-acquired or hospital-acquired pneumonia requiring hospitalization, and certain cardiovascular conditions or risks.

Written informed consent is required before participation.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes evaluating levels of high-sensitivity cardiac Troponin (hs-cTn), which is a protein released when the heart muscle is damaged.

Other assessments include electrocardiographic and echocardiographic evaluations to check heart function and structure.

3 treatment administration

The treatment involves the administration of TAD® 600 mg/4 ml solution for injection, which contains glutathione, a substance that may help prevent heart injury.

The medication is given intravenously, meaning it is delivered directly into a vein.

4 ongoing assessments

Throughout the study, regular assessments are conducted to monitor changes in hs-cTn levels and other heart-related parameters.

These assessments help evaluate the effectiveness and safety of the treatment in preventing heart injury.

5 final evaluation

At the end of the study, a final evaluation is performed to compare the initial and ongoing assessment results.

This includes a comprehensive review of any adverse reactions or events experienced during the trial.

Who Can Join the Study?

  • Patients must be between the ages of 18 and 80 years old.
  • Patients must have a diagnosis of pneumonia that requires them to be in the hospital. Pneumonia is an infection that inflames the air sacs in one or both lungs.
  • Patients must have at least one of the following heart-related conditions or risks:
    • Hypertension: This means having high blood pressure.
    • Permanent atrial fibrillation: A condition where the heart beats irregularly and often rapidly.
    • History of ischemic heart disease: This means having had problems with blood flow to the heart.
    • Heart failure: A condition where the heart doesn’t pump blood as well as it should.
    • Diabetes: A disease that affects how the body uses blood sugar.
    • Cardiac Valvular Disease: Problems with one or more of the heart valves.
    • Previous episode of myocarditis or pericarditis: These are conditions where the heart muscle or the lining around the heart is inflamed, and it must have occurred at least 6 months ago.
    • Chronic kidney disease: A long-term condition where the kidneys do not work as well as they should, with a specific measure of kidney function between 30 and 60.
  • Patients can also participate if they are at a very high risk of developing heart-related diseases based on specific risk models. These models use scores to estimate the risk:
    • For patients under 50 years old, the score must be 7.5% or higher.
    • For patients aged 50 to 69 years old, the score must be 10% or higher.
    • For patients 70 years old or older, the score must be 15% or higher.
  • Patients must agree to participate by signing a written consent form that has been approved by an Ethics Committee. This means they understand the study and agree to be part of it.

Who Cannot Join the Study?

  • Patients who are not affected by pneumonia cannot participate.
  • Patients who do not have a risk of myocardial injury cannot participate. Myocardial injury refers to damage to the heart muscle.
  • Patients who are not hospitalized cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like pregnant women, children, or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Universita’ Campus Bio-medico Di Roma Rome Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Universita’ Di Pisa Pisa Italy
Ubhdxojedz Ddrjl Smrwl Dx Rvpx Lz Sxnawjwj Rome Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.12.2023

Trial locations

Investigated drugs:

TAD® is a medication being studied for its potential to prevent heart damage in patients with pneumonia. It is given as an injection and contains a substance called sodium salt glutathione, which may help protect the heart. The study aims to determine if TAD® is both effective and safe for this purpose.

Investigated diseases:

Myocardial injury in patients affected by pneumonia – This condition occurs when the heart muscle is damaged in individuals who are suffering from pneumonia. Pneumonia is an infection that inflames the air sacs in one or both lungs, which can fill with fluid or pus. The inflammation and infection can lead to stress on the heart, potentially causing injury to the heart muscle. This injury is often indicated by elevated levels of cardiac biomarkers such as high-sensitivity cardiac Troponin (hs-cTn). The progression of myocardial injury can vary, but it generally involves changes in heart function and structure, which may be monitored through various cardiac assessments. These assessments can include electrocardiograms, echocardiograms, and measurements of specific proteins in the blood that indicate heart stress or damage.

Trial ID:
2023-503950-11-00
Protocol code:
GLT-07-22
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on High-Dose Short-Course Antibiotics for Critically Ill Patients with Pneumonia, Intra-Abdominal, or Bloodstream Infections: Ceftriaxone, Linezolid, and Cefotaxime

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium The Netherlands

  • Study on the Effect of Amoxicillin in Preschool Children with Pneumonia

    Recruiting

    3 1 1
    Investigated drugs:
    Norway