Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.
Recruiting
Phase 3
Interventional Study
Pneumonia
Myocardial Injury
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 178 (estimated)
- Sponsor
- Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica · Industry
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About This Trial
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 …
Trial Locations
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Eligibility 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
*…
Contacts