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Tests treatment safety and results for Pneumonia
Official title Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.
ClinicalTrials.gov ID: NCT06296212
What this study is testing
What is TAD® 600 mg/4 mL powder and solvent for solution for injection?
TAD® 600 mg/4 mL powder and solvent for solution for injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia. The main question it aims to answer is: could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients with an age of ≥ 18 and ≤ 80 years
- Diagnosis of CAP or HAP requiring hospitalization
- Patients with one of the following : \- At least one cardiovascular comorbidity:
- Chronic atrial fibrillation
- History of ischemic heart disease (≥ 3 months)
You likely can't join if
- Medical Conditions:
- Active malignancy
- Severe heart failure (NYHA class III and IV)
- End-stage renal failure (eGFR \< 30 mL/min)
- Severe liver disease
- History of hypersensitivity to glutathione or any excipients
See the full eligibility criteria
- Patients with an age of ≥ 18 and ≤ 80 years
- Diagnosis of CAP or HAP requiring hospitalization
- Patients with one of the following : \- At least one cardiovascular comorbidity:
- Chronic atrial fibrillation
- History of ischemic heart disease (≥ 3 months)
- Heart failure
- Cardiac Valvular Disease
- Previous (≥ 6 months) episode of myocarditis or pericarditis. \- Very high risk of developing cardiovascular diseases according to the SCORE2 and SCORE2-OP risk models for moderate risk European regions (score ≥ 7.5%...
- Provision of written informed consent as approved by the Ethics Committee (EC).
- Medical Conditions:
- Active malignancy
- Severe heart failure (NYHA class III and IV)
- End-stage renal failure (eGFR \< 30 mL/min)
- Severe liver disease
- History of hypersensitivity to glutathione or any excipients
- Use of drugs containing sacubitril
- Use of drugs with antioxidant activity in the last 3 months
- Use of narcotics
- Use of invasive mechanical ventilation
- Recent (\< 3 months) ACS (STEMI, NSTEMI, UA), myocardial revascularization, myocarditis, acute pericarditis episodes. General Conditions:
- Pregnant or breastfeeding women
- Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
- Participation in other investigational drug or device clinical trials within 30 days prior to study screening
- Patients legally or mentally incapacitated unable to give informed consent for the participation in this trial
- Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Pisa, PI, Italy
- Roma, RM, Italy
- Terni, TR, Italy
- Treviso, TV, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pisa, PI, Italy; Roma, RM, Italy; Terni, TR, Italy; Treviso, TV, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.