PneumoniaPhase 3NCT06296212
Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.
A Phase 3 study testing TAD® 600 mg/4 mL powder and solvent for solution for injection and Saline solution 0.9% of sodium chloride in people with Pneumonia and Myocardial Injury, run by Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonia, Myocardial Injury
- What is being tested?
- TAD® 600 mg/4 mL powder and solvent for solution for injection and Saline solution 0.9% of sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 7 sitesItaly
- Study dates
- 25 Jun 2024to 30 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56126
Massimiliano Desideri
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, RM, 00128
Francesco Grigioni
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, RM, 00133
Francesco Barillà
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, RM, 00161
Pasquale Pignatelli
- Recruiting
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, RM, 00189
Alberto Ricci
- Recruiting
Azienda Ospedaliera Santa Maria
Terni, TR, 05100
Giacomo Pucci
- Recruiting
Ospedale Ca' Foncello
Treviso, TV, 31100
Marcello Rattazzi
About this study
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.
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:
Read more
- 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
- Pneumonia, Myocardial Injury
- Being tested
- TAD® 600 mg/4 mL powder and solvent for solution for injection, Saline solution 0.9% of sodium chloride
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAD® 600 mg/4 mL powder and solvent for solution for injectionDrug
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 0.9% of sodium chlorideDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| TAD® 600 mg/4 mL Solution for Injection | Experimental | 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). Receives: Drug: TAD® 600 mg/4 mL powder and solvent for solution for injection |
| Saline solution of 0.9% sodium chloride | Placebo comparator | 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). Receives: Drug: Saline solution 0.9% of sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups.
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.
Measured: 7-9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start25 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noemi Evangelisti, Study director, Biomedica Foscama S.p.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296212
- Sponsor's protocol ID
- GLT-07-22
- Status last verified
- Jul 2024
- First submitted
- 27 Feb 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06296212
- Acronym / sponsor ID
- GLT-07-22
- Conditions
- Pneumonia, Myocardial Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Biomedica Foscama S.p.A. Industria Chimico-FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAD® 600 mg/4 mL Solution for Injection | Experimental | Drug: TAD® 600 mg/4 mL powder and solvent for solution for injectionTAD® 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 | Placebo comparator | Drug: Saline solution 0.9% of sodium chloridePlacebo (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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with an age of ≥ 18 and ≤ 80 years
- Diagnosis of CAP or HAP requiring hospitalization
- Patients with one of the following :
- Chronic atrial fibrillation
- History of ischemic heart disease (≥ 3 months)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAD® 600 mg/4 mL powder and solvent for solution for injectionTAD® 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). | Drug | TAD® 600 mg/4 mL Solution for Injection |
| Saline solution 0.9% of sodium chloridePlacebo (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). | Drug | Saline solution of 0.9% sodium chloride |
Primary outcome
Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noemi Evangelisti study director
Biomedica Foscama S.p.A
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAD® 600 mg/4 mL powder and solvent for solution for injection and Saline solution 0.9% of sodium chloride in people with Pneumonia and Myocardial Injury, run by Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noemi Evangelisti (07751509595, n.evangelisti@foscamaspa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups. (time frame: 7-9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.