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NCT06296212 | RECRUITING | Pneumonia

Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.
Sponsor:

Biomedica Foscama S.p.A. Chemical-Pharmaceutical Industry

Brief Summary:

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? Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment. Eligible patients who meet the study inclusion criteria and complete the required Screening \& Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI \& Patient blinded. TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered: * intravenously (with an infusion rate of 10 mL/min) * 2 times a day (with a dosing interval of 8 hours ± 30 minutes) * for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5) * patients will then be required to undergo five Follow-up Visits.

Condition or disease

Pneumonia

Myocardial Injury

Intervention/treatment

TAD® 600 mg/4 mL powder and solvent for solution for injection

Saline solution 0.9% of sodium chloride

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 178 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Multicenter, Randomized, Double-blind, Phase III Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.
Actual Study Start Date : 2024-06-25
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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% for patients \< 50 years old, score ≥ 10% for patients 50-69 years old, and score ≥ 15% for patients ≥ 70 years old).
    • * Provision of written informed consent as approved by the Ethics Committee (EC).
    Exclusion Criteria
  • 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.
    • Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.

    Location Details

    NCT06296212

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    Italy, PI

    Pisan University Hospital Company

    Pisa, PI, Italy, 56126

    RECRUITING

    Italy, RM

    Campus Bio-Medico University Polyclinic Foundation

    Roma, RM, Italy, 00128

    RECRUITING

    Italy, RM

    Tor Vergata Polyclinic University Hospital

    Roma, RM, Italy, 00133

    RECRUITING

    Italy, RM

    Policlinico Umberto I University Hospital

    Roma, RM, Italy, 00161

    RECRUITING

    Italy, RM

    Sant'Andrea University Hospital

    Roma, RM, Italy, 00189

    RECRUITING

    Italy, TR

    Santa Maria Hospital Company

    Terni, TR, Italy, 05100

    RECRUITING

    Italy, TV

    Ca' Foncello Hospital

    Treviso, TV, Italy, 31100