Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.
- Conditions
- PneumoniaMyocardial Injury
- Interventions
- Drug: TAD® 600 mg/4 mL powder and solvent for solution for injectionDrug: Saline solution 0.9% of sodium chloride
- Registration Number
- NCT06296212
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAD® 600 mg/4 mL Solution for Injection TAD® 600 mg/4 mL powder and solvent for solution for injection TAD® 600 mg/4 mL powder and solvent for solution for injection, 1 vial powder (glutathione sodium salt 646 mg) + 1 solvent ampoule (4 mL water for injection) reconstituted solution in 50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes). Saline solution of 0.9% sodium chloride Saline solution 0.9% of sodium chloride Placebo (50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes).
- Primary Outcome Measures
Name Time Method Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups. 7-9 days Change of levels of high-sensitivity cardiac Troponin (hs-cTn) between V1 and V0 will be calculated. The non-paired T test or Mann Whitney test will be used to compare changes between groups.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, PI, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, RM, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
🇮🇹Roma, RM, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
🇮🇹Roma, RM, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
🇮🇹Roma, RM, Italy
Azienda Ospedaliera Santa Maria
🇮🇹Terni, TR, Italy
Ospedale Ca' Foncello
🇮🇹Treviso, TV, Italy