NCT06496997 A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome
| NCT ID | NCT06496997 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Fayoum University |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-08 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2024-08-01 with a primary completion date of 2025-08.
⚠ 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 aim of the work is to compare the efficacy of equivalent doses of methylprednisolone, dexamethasone and hydrocortisone in patients with ARDS
Eligibility Criteria
Inclusion Criteria: We include patients receiving mechanical ventilation for hypoxemic respiratory failure if they met the diagnostic criteria for ARDS according to the American-European Consensus definition, as later reclassified on the basis of the 2012 Berlin criteria for the diagnosis of ARDS, defined as: 1. Presence of acute hypoxemic respiratory failure (an arterial oxygen partial pressure to fraction of inspired oxygen ratio (PaO2/FiO2) of ≤ 300 mm Hg, requiring supplemental oxygen administrated by simple face mask, nasal cannula, or other similar oxygen-delivery device to maintain oxygen saturation at greater than 93% within the first 48 h of the onset of ARDS) 2. Onset within 7 days of insult, or new (within 7 days) or worsening respiratory symptoms 3. Bilateral opacities on chest x-ray or CT not fully explained by effusions, lobar or lung collapse, or nodules 4. Cardiac failure not the primary cause of acute respiratory failure Exclusion Criteria: We exclude patients with acute hypoxemic respiratory failure caused by congestive heart failure
Contact & Investigator
Mahmoud Ezzat Elkmash, Teaching Assistant
PRINCIPAL INVESTIGATOR
Faculty of Pharmacy - Fayoum University
Frequently Asked Questions
Who can join the NCT06496997 clinical trial?
This trial is open to participants of all sexes, studying Acute Respiratory Distress Syndrome. 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 NCT06496997 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06496997 currently recruiting?
Yes, NCT06496997 is actively recruiting participants. Contact the research team at mam54@fayoum.edu.eg for enrollment information.
Where is the NCT06496997 trial being conducted?
This trial is being conducted at Al Fayyum, Egypt.
Who is sponsoring the NCT06496997 clinical trial?
NCT06496997 is sponsored by Fayoum University. The principal investigator is Mahmoud Ezzat Elkmash, Teaching Assistant at Faculty of Pharmacy - Fayoum University. The trial plans to enroll 300 participants.