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

NCT04545242 | Completed Phase 4 DMC

• 1 other identifier: ICI20-00062
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 40

Brief 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

Keywords

Acute respiratory failure; ARDS; Mechanical ventilation; Infection

Outcome Measures

Primary Outcomes (1)

• 60-day mortality

  All-cause mortality at 60 days after randomization

  60 days

Secondary Outcomes (1)

• Ventilator-free days

  28 days

Study Arms (2)

Dexamethasone (low dose)

ACTIVE COMPARATOR

Dexamethasone: 6 mg/iv/day during 10 days.

Drug: Dexamethasone

Dexamethasone (moderate dose)

ACTIVE COMPARATOR

Dexamethasone: 20 mg/iv/ daily from day of randomization (day 1) during 5 days, followed by 10 mg/iv/ daily from Day 6 to Day 10 of randomization.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

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

Also known as: Decadron, Dexasone, Diodex

Dexamethasone (low dose); Dexamethasone (moderate dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older;
• intubated and mechanically ventilated;
• acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
• Pulmonary or systemic infectious etiology of AHRF.

You may not qualify if:

• Patients with a known contraindication to corticosteroids,
• Patient included in another therapeutic clinical trial
• Lack of informed consent

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Hospital Universitario de Gran Canaria Doctor Negrín: lead
• Li Ka Shing Knowledge Institute: collaborator

Study Sites (40)

Hospital Universitario Mutua Terrassa (ICU)

Terrassa, Barcelona, 08221, Spain

Location

Hospital General La Mancha Centro (ICU)

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Complejo Hospitalario Universitario de Santiago (Anesthesia)

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital General El Bierzo (ICU)

Ponferrada, León, 24404, Spain

Location

Hospital Universitario del Henares (ICU)

Coslada, Madrid, 28822, Spain

Location

Hospital Universitario de Getafe (ICU)

Getafe, Madrid, 28905, Spain

Location

Hospital Universitario Severo Ochoa (ICU)

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Puerta de Hierro (ICU)

Majadahonda, Madrid, 28222, Spain

Location

Hospital Nuestra Señora del Prado (ICU)

Talavera de la Reina, Toledo, 45600, Spain

Location

Hospital Universitario de Cruces (Anesthesia)

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario de Cruces (ICU)

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario de A Coruña (ICU)

A Coruña, 15006, Spain

Location

Complejo Hospitalario Universitario de Albacete (ICU)

Albacete, 02006, Spain

Location

Hospital Clinic de Barcelona (AVI)

Barcelona, 08036, Spain

Location

Hospital Clinic de Barcelona (Cardiac ICU)

Barcelona, 08036, Spain

Location

Hospital Clínic (Hepatic ICU)

Barcelona, 08036, Spain

Location

Hospital Clínic de Barcelona (Anesthesia)

Barcelona, 08036, Spain

Location

Hospital General de Ciudad Real (ICU)

Ciudad Real, 13005, Spain

Location

Hospital Virgen de la Luz (ICU)

Cuenca, 16002, Spain

Location

Complejo Asistencial Universitario de León (ICU)

León, 24001, Spain

Location

Hospital Universitario La Princesa (ICU)

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal (Anesthesia)

Madrid, 28034, Spain

Location

Hospital Clínico Universitario San Carlos (ICU)

Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz (ICU)

Madrid, 28040, Spain

Location

Hospital Universitario Doce de Octubre (ICU)

Madrid, 28041, Spain

Location

Hospital Universitario La Paz (Anesthesia)

Madrid, 28046, Spain

Location

Hospital Universitario La Paz (ICU)

Madrid, 28046, Spain

Location

Hospital Universitario Regional de Malaga Carlos Haya (ICU)

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de Arrixaca (Anesthesia)

Murcia, 30120, Spain

Location

Hospital Universitario Virgen de Arrixaca (ICU)

Murcia, 30120, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Montecelo (Anesthesia)

Pontevedra, 36071, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria (ICU)

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital General de Segovia (ICU)

Segovia, 40002, Spain

Location

Hospital Clinico Universitario de Valencia (Anesthesia)

Valencia, 46010, Spain

Location

Hospital Clinico Universitario de Valencia (ICU)

Valencia, 46010, Spain

Location

Hospital Clínico Universitario de Valladolid (Anesthesia)

Valladolid, 47003, Spain

Location

Hospital Universitario Río Hortega (Anesthesia)

Valladolid, 47012, Spain

Location

Hospital Universitario Río Hortega (ICU)

Valladolid, 47012, Spain

Location

Hospital Virgen de la Concha (ICU)

Zamora, 49022, Spain

Location

Related Publications (2)

• Villar J, Ferrando C, Martinez D, Ambros A, Munoz T, Soler JA, Aguilar G, Alba F, Gonzalez-Higueras E, Conesa LA, Martin-Rodriguez C, Diaz-Dominguez FJ, Serna-Grande P, Rivas R, Ferreres J, Belda J, Capilla L, Tallet A, Anon JM, Fernandez RL, Gonzalez-Martin JM; dexamethasone in ARDS network. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Mar;8(3):267-276. doi: 10.1016/S2213-2600(19)30417-5. Epub 2020 Feb 7.

  PMID: 32043986 BACKGROUND

• RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.

  PMID: 32678530 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Infections

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jesús Villar, MD

  Hospital Universitario Dr. Negrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior scientist

Model Details: Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with AHRF (including ARDS) caused by confirmed bacterial or viral infections.

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 10, 2020
• Study Start: July 6, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (40)