The goal of this clinical trial is to learn if R-3750 is safe in \[in patients with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) . The main question\[s\] it aims to answer are:
1. the favorable safety profile 2. clinical improvement that includes reduced ventilator dependence and improved lung function.
Participants will be given oral capsules daily and/or enteral nasogastric or orogastric (NG/OG tube) if necessary.
Age ≥18 years at the time of consent.
Hypoxemia defined as PaO2/FiO2 ≤300 mmHg, or SpO2/FiO2 ≤315 if SpO2 is ≤97%;
Bilateral pulmonary infiltrates/opacities on chest imaging consistent with pulmonary edema or fibroproliferative lung injury and not fully explained by pleural effusions, lobar collapse, or atelectasis;
Requirement for positive pressure respiratory support, including invasive mechanical ventilation via endotracheal tube;
Age <18 years.
More than 28 days since onset of ARDS at the time of enrollment.
ARDS that is clearly resolving rapidly, in the judgment of the investigator, such that enrollment in a 28-day rescue-therapy study is not clinically appropriate.
Pregnancy or breastfeeding.
Sequential
R-3750
DrugR-3750 is an investigational live biotherapeutic product administered once daily at either 9 × 10⁹ CFU/day or 9 × 10¹⁰ CFU/day. Study treatment may be administered orally as capsules or enterally via nasogastric (NG) or orogastric (OG) tube when oral administration is not feasible.
To assess the safety and tolerability of R-3750 administered to participants with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS)
To assess the number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory parameters, abnormal vital signs, abnormal physical examination findings throughout the study.
All-cause mortality
Proportion of participants who are alive at Day 90.
Ventilator-free days
Number of days alive and free from invasive mechanical ventilation.
Organ failure-free days
Number of days alive and free from organ failure.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
