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Glutathione

Clinical trials are investigating Glutathione in hospitalized patients with pneumonia, especially to see whether it can help prevent heart muscle injury. These studies look at safety and efficacy in a controlled setting, with outcomes such as cardiac troponin changes.

Table of Contents

Trial overview

The available trial studies Glutathione in hospitalized patients with pneumonia to see whether it can help prevent myocardial injury, which means damage to the heart muscle.[1]

This is a Phase 3 study, which means it is a later-stage trial designed to test the treatment in a larger group of people.[1]

The study is authorised and planned to enroll 178 participants.[1]

Study design and treatment groups

The trial is described as multicenter, randomized, and double-blind.[1]

Multicenter means the study is being run at more than one site, which can help include a wider range of patients.[1]

Randomized means participants are assigned to study groups by chance, and double-blind means neither the participants nor the study team know who receives which treatment.[1]

The intervention group receives intravenous TAD® 600 mg/4 ml solution for injection, described in the trial data as a drug containing the sodium salt glutathione.[1]

The comparison group receives intravenous sodium chloride 0.9% infusion, which is a standard infusion solution used as the control treatment in this study.[1]

Who can participate

The trial is aimed at hospitalized patients with pneumonia.[1]

The condition being studied is myocardial injury in patients affected by pneumonia, so the study focuses on people who are already admitted to the hospital and have this infection.[1]

No other detailed eligibility rules are provided in the trial data, so the main known target population is hospitalized adults with pneumonia at risk of heart muscle injury.[1]

What the trial is measuring

The main endpoint is the change in high-sensitivity cardiac Troponin (hs-cTn) between two study visits, called V0 and V1, in the two treatment groups.[1]

hs-cTn is a blood marker that can rise when the heart muscle is injured, so measuring it helps researchers see whether the treatment may prevent heart damage.[1]

The brief summary states that TAD® may be effective and safe as an add-on treatment in this setting, but the trial data provided here only confirms that efficacy and safety are being evaluated.[1]

Why this trial matters

Pneumonia can be serious enough to affect more than the lungs, and this study is focused on whether Glutathione may help protect the heart during hospitalization.[1]

Because the trial uses a controlled design with randomization and blinding, it is set up to give a more reliable answer about whether the treatment changes hs-cTn levels.[1]

For patients and families, the key point is that this research is not about routine use, but about testing whether Glutathione can reduce heart injury in a specific group of hospitalized pneumonia patients.[1]

Trial ID Phase Condition studied Status Enrollment
2023-503950-11-00 Phase 3 Myocardial injury in patients affected by pneumonia Authorised 178

FAQ

  • What is being studied in Glutathione clinical trials? The trial is studying whether Glutathione, given intravenously as TAD®, can help prevent myocardial injury in patients with pneumonia. The main focus is on safety and whether heart injury markers improve.
  • Who can take part in these trials? The trial is for hospitalized patients with pneumonia. It is aimed at people at risk of myocardial injury during their hospital stay.
  • What phase is the Glutathione trial? The study is a Phase 3 trial. Phase 3 studies usually compare treatments in larger groups to see how well they work and how safe they are.
  • What condition is the trial targeting? The trial targets myocardial injury in patients affected by pneumonia. Myocardial injury means damage to the heart muscle.
  • What outcome is the trial measuring? The main outcome is the change in high-sensitivity cardiac Troponin, or hs-cTn, between two study visits. Troponin is a blood marker that can rise when the heart muscle is injured.

Ongoing Clinical Trials on Glutathione

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

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, works well, or both.
  • Randomized: Participants are placed into study groups by chance, not by choice. This helps make the results fair.
  • Double-blind: Neither the participants nor the study team know who receives which treatment. This helps reduce bias.
  • Phase 3: A later-stage trial that studies a treatment in a larger group of people to better understand its effects and safety.
  • Interventional study: A trial where researchers give a treatment and then measure what happens.
  • Myocardial injury: Damage to the heart muscle.
  • Pneumonia: An infection in the lungs that can make breathing difficult and may affect other organs.
  • High-sensitivity cardiac Troponin (hs-cTn): A blood test marker that can show very small amounts of heart muscle injury.
  • Intravenous: Given through a vein.
  • Enrollment: The number of people planned to join a study.
  • Authorised: The study has been approved to start.

References

  1. https://clinicaltrials.gov/study/2023-503950-11-00