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Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

NCT04545242 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2025-08-26

No results posted yet for this study

Summary

Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.

Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.

Conditions

  • Acute Hypoxemic Respiratory Failure

Interventions

DRUG

Dexamethasone

Intravenous dexamethasone (low vs. moderate doses) during 10 days

Sponsors & Collaborators

  • Li Ka Shing Knowledge Institute

    collaborator UNKNOWN

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    collaborator OTHER_GOV

  • Dr. Negrin University Hospital

    lead OTHER

Principal Investigators

  • Jesús Villar, MD · Hospital Universitario Dr. Negrin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545242 on ClinicalTrials.gov