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Compares treatment options for Healthcare-Associated Pneumonia
Official title HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
ClinicalTrials.gov ID: NCT05354778
What this study is testing
What is Hydrocortisone?
Hydrocortisone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthcare-associated pneumonia.
Also referred to as Solu-CORTEF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older
- Suspected ou confirmed case of bacterial nosocomial pneumonia (including ventilator-associated pneumonia)
- Intensive Care Unit stay
- Signed consent form (by the patient or a legal guardian)
You likely can't join if
- Women who are pregnant, have recently given birth or are breastfeeding
- Patients who are moribund or do not have a treatment perspective
- Patients with community acquired pneumonia
- Patients with other types of pneumonia (viral - including COVID-19, fungal etc.)
- Those with pulmonary infiltrates in chest image which are not compatible with bacterial pneumonia
- Patients with adrenal insufficiency
See the full eligibility criteria
- 18 years of age or older
- Suspected ou confirmed case of bacterial nosocomial pneumonia (including ventilator-associated pneumonia)
- Intensive Care Unit stay
- Signed consent form (by the patient or a legal guardian)
- Women who are pregnant, have recently given birth or are breastfeeding
- Patients who are moribund or do not have a treatment perspective
- Patients with community acquired pneumonia
- Patients with other types of pneumonia (viral - including COVID-19, fungal etc.)
- Those with pulmonary infiltrates in chest image which are not compatible with bacterial pneumonia
- Patients with adrenal insufficiency
- Patients who have a condition that demands the use of corticosteroids (acute or chronic)
- Patients allergic to hydrocortisone
- Patients with refractory septic shock (those receiving more than 0,5mcg/kg/min of norepinephrine)
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, Sao Paulo SP, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, Sao Paulo SP, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.