NCT07711964 Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome
| NCT ID | NCT07711964 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-06-15 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-06-15 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades. Although their efficacy has been a subject of ongoing controversy, recent clinical practice guidelines for ARDS issued a weak recommendation in favor of corticosteroid use in early ARDS. However, the optimal dose and duration of corticosteroid therapy remain unclear. Low-dose, short-course regimens have been evaluated in clinical trials for severe pneumonia and COVID-19. However, no head-to-head comparisons have been conducted to evaluate the efficacy of prolonged versus short courses of corticosteroid therapy in ARDS. To address this gap, the investigators designed a 3×2 factorial trial to assess corticosteroid therapy for ARDS, aiming to evaluate the effects of different doses (no steroid, medium-low dose, and medium dose) and durations (prolonged vs. short) on clinical outcomes. In addition, the investigators will measure changes in inflammatory biomarkers for post hoc analysis to explore whether these biomarkers could guide the selection of steroid regimens.
Eligibility Criteria
Inclusion Criteria: * ARDS (as defined by the Berlin definition) with an FiO₂ of 0.5 or higher * On invasive mechanical ventilation * Duration of intubation less than three days Exclusion Criteria: * Age less than 18 years * Required to receive steroids or considered ineligible for steroids by the primary care team * Receiving systemic steroid therapy * Uncontrolled gastrointestinal bleeding * Uncontrolled infeciotn
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07711964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07711964 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07711964 currently recruiting?
Yes, NCT07711964 is actively recruiting participants. Contact the research team at syruan@ntu.edu.tw for enrollment information.
Where is the NCT07711964 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07711964 clinical trial?
NCT07711964 is sponsored by National Taiwan University Hospital. The trial plans to enroll 300 participants.