protocolSection identificationModule nctId: NCT06296212, orgStudyIdInfo id: GLT-07-22, briefTitle: Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Pneumonia, conditions: Myocardial Injury, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule interventions name: TAD® 600 mg/4 mL powder and solvent for solution for injection, interventions name: Saline solution 0.9% of sodium chloride, outcomesModule primaryOutcomes measure: Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria Pisana, city: Pisa, state: PI, zip: 56126, country: Italy, contacts name: Massimiliano Desideri, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Fondazione Policlinico Universitario Campus Bio-Medico, city: Roma, state: RM, zip: 00128, country: Italy, contacts name: Francesco Grigioni, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata, city: Roma, state: RM, zip: 00133, country: Italy, contacts name: Francesco Barillà, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I, city: Roma, state: RM, zip: 00161, country: Italy, contacts name: Pasquale Pignatelli, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Sant'Andrea, city: Roma, state: RM, zip: 00189, country: Italy, contacts name: Alberto Ricci, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliera Santa Maria, city: Terni, state: TR, zip: 05100, country: Italy, contacts name: Giacomo Pucci, role: CONTACT, geoPoint lat: 42.56335, lon: 12.64329, locations facility: Ospedale Ca' Foncello, city: Treviso, state: TV, zip: 31100, country: Italy, contacts name: Marcello Rattazzi, role: CONTACT, geoPoint lat: 45.66673, lon: 12.2416, hasResults: False