Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06296212

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

Led by Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica · Updated on 2024-11-27

178

Participants Needed

7

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

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.

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 80 years
  • Diagnosis of community-acquired or hospital-acquired pneumonia requiring hospitalization
  • Presence of at least one cardiovascular comorbidity: chronic atrial fibrillation, history of ischemic heart disease (3 months or more), heart failure, cardiac valvular disease, or previous myocarditis or pericarditis episode (6 months or more)
  • Very high risk of cardiovascular disease based on SCORE2 and SCORE2-OP risk models
  • Provision of written informed consent approved by the Ethics Committee
Not Eligible

You will not qualify if you...

  • Active malignancy
  • Severe heart failure (NYHA class III or IV)
  • End-stage renal failure (eGFR less than 30 mL/min)
  • Severe liver disease
  • History of allergy 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 acute coronary syndrome, myocardial revascularization, myocarditis, or acute pericarditis episodes within 3 months
  • Pregnant or breastfeeding women
  • Women of child-bearing potential not using effective contraception
  • Participation in other investigational drug or device trials within 30 days
  • Legal or mental incapacity preventing informed consent
  • Inability or unwillingness to comply with study appointments and protocol requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy, 56126

Actively Recruiting

2

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, Italy, 00128

Actively Recruiting

3

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Roma, RM, Italy, 00133

Actively Recruiting

4

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, RM, Italy, 00161

Actively Recruiting

5

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, RM, Italy, 00189

Actively Recruiting

6

Azienda Ospedaliera Santa Maria

Terni, TR, Italy, 05100

Actively Recruiting

7

Ospedale Ca' Foncello

Treviso, TV, Italy, 31100

Actively Recruiting

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Research Team

N

Noemi Evangelisti

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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