Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296212
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-02-27
Brief Title:
Study of Intravenous TAD 600 mg4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia
Sponsor:
Biomedica Foscama SpA Industria Chimico-Farmaceutica
Organization:
Biomedica Foscama SpA Industria Chimico-Farmaceutica
Study Overview
Official Title:
Multicenter Randomized Double-blind Phase III Study of Intravenous TAD 600 mg4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD 600 mg4 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 11 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 mg4 mL reconstituted solution in 50 mL of 09 sodium chloride solution or Placebo 50 mL of 09 sodium chloride solution will be administered
intravenously with an infusion rate of 10 mLmin
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
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 11 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 mg4 mL reconstituted solution in 50 mL of 09 sodium chloride solution or Placebo 50 mL of 09 sodium chloride solution will be administered
intravenously with an infusion rate of 10 mLmin
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None