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HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study

NCT05354778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-25

No results posted yet for this study

Summary

The use of corticosteroids in patients with severe community pneumonia, bacterial infection which kills lots of patients around the world, reduces the mortality of this infection. However, there are no studies with this type of drug regarding hospital-acquired pneumonia. This is the first multicenter randomized trial to test hydrocortisone plus standard therapy in critical care patients with nosocomial pneumonia. This intervention is inexpensive and may improve the outcome of those patients, besides having an acceptable side effects profile.

Conditions

  • Healthcare-Associated Pneumonia
  • Ventilator Associated Pneumonia

Interventions

DRUG

Hydrocortisone

Corticosteroid

DRUG

Placebo

Normal saline only

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    collaborator OTHER

  • Hospital de Câncer de Barretos

    collaborator OTHER

  • University of Sao Paulo

    collaborator OTHER

  • Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

    lead OTHER

Principal Investigators

  • João Manoel Silva Junior, MD · Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-16
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Brazil

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 NCT05354778 on ClinicalTrials.gov