Healthcare-Associated PneumoniaHYDRO-SHIPNCT05354778
HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
A study testing Hydrocortisone in people with Healthcare-Associated Pneumonia and Ventilator Associated Pneumonia, run by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare-Associated Pneumonia, Ventilator Associated Pneumonia
- What is being tested?
- Hydrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Oct 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital do Servidor Publico Estadual
São Paulo, Sao Paulo SP, 04039-901
About this study
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.
Read the detailed description
Introduction and Objectives: the use of corticosteroids in patients with severe community pneumonia reduces morbimortality. However, to our knowledge, there are no studies with steroids for patients in intensive care with nosocomial pneumonia, among which those with ventilator associated pneumonia, infections which carry a high mortality rate. The treatment for those diseases involves intensive care and antibiotics, but there is a need for inexpensive, adjuvant therapies which improve the outcome for those patients. Therefore, the objective of this study is to compare hydrocortisone versus placebo, both with standard therapy, in the outcome of critical care patients diagnosed with nosocomial pneumonia. Methods: multicenter randomized, open-label, controlled trial, with two parallel groups: hydrocortisone or placebo, associated with nosocomial pneumonia's standard treatment. Patients with viral or other etiologies of pneumonia are excluded, as well as corticosteroids chronical users, or patients with conditions which demand this type of therapy. Intravenous 100mg of hydrocortisone and normal saline (the placebo) are tested every eight hours for five days or until intensive care unit (ICU) discharge or until the patient dies. The sample is 180 patients, 90 in each group, in different ICUs in Brazil. The primary outcome is early clinical failure. The secondary outcomes are survival and mortality in both groups, need for intubation, mechanical ventilation, vasoactive drugs and dialysis, lengths of stay in the hospital and in the ICU, radiological progression and adverse events. Discussion, risks, and benefits: 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. Weighing the benefits and risks of this study, as well as its strengths and potential weaknesses, it is believed that its realization is justified, in addition to bringing important advances in the field of intensive care.
- Being tested
- Hydrocortisone, Placebo
- Keywords
- Hydrocortisone, Intensive Care Unit, Pneumonia, Steroids, Critical Care
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Solu-CORTEF
Corticosteroid
PlaceboDrug
Also called NS
Normal saline only
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit Receives: Drug: Placebo |
| Hydrocortisone | Active comparator | Hydrocortisone 100mg + normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Clinical Failure
Composite outcome: Death OR Respiratory worsening OR Cardiovascular worsening
Measured: Between days 0 and 7 for death; between days 3 and 7 for respiratory or cardiovascular worsening
Secondary outcomes (13)
Survival
In the intensive care unit and in the hospital
Measured: Days 7 and 28
Respiratory failure
Need for mechanical ventilation
Measured: 7 days
Septic shock
Need for vasoactive drugs
Measured: 7 days
Time of mechanical ventilation
Number of days patients require invasive ventilation support
Measured: 7 days
Ventilator parameters (1)
Positive end expiratory pressure (PEEP)
Measured: 7 days
Ventilator parameters (2)
Inspired oxygen fraction (FiO2)
Measured: 7 days
Arterial blood gas analysis
Partial pressure of oxygen (PaO2)
Measured: 7 days
Respiratory condition
Horowitz index for lung function (P/F ratio) - obtained from PaO2/FiO2
Measured: 7 days
Time of vasoactive drugs use
Dosage and types of vasoactive drugs
Measured: 7 days
Length of stay
In the Intensive Care Unit and in the hospital
Measured: 28 days
Need for renal substitution therapy
Need for dialysis
Measured: 7 days
Radiological worsening
Progression of image in the chest X-ray image
Measured: 7 days
Adverse effects
psychosis, insomnia, hyperglycemia, hypernatremia, rhabdomyolysis, gastrointestinal bleeding and critical myopathy illness
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start16 Oct 2022
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Healthcare-Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, open-label clinical trial with two parallel groups: hydrocortisone and placebo. Data analyzed as "intention-to-treat".
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto do Cancer do Estado de São Paulo, Hospital de Câncer de Barretos, University of Sao Paulo
- Responsible party
- Principal investigator, João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Investigators
- João Manoel Silva Junior, MD, Principal investigator, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354778
- Sponsor's protocol ID
- 54214821.0.1001.0068
- Acronym
- HYDRO-SHIP
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.
PubMed 12186604Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J; CORTICUS Study Group. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24. doi: 10.1056/NEJMoa071366.
PubMed 18184957Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
PubMed 29490185Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers SC, Russell JA, Van den Berghe G. Guidelines for the Diagnosis and Management of Critical Illness-Related Corticosteroid Insufficiency (CIRCI) in Critically Ill Patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Crit Care Med. 2017 Dec;45(12):2078-2088. doi: 10.1097/CCM.0000000000002737.
PubMed 28938253RECOVERY 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.
PubMed 32678530WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group; Sterne JAC, Murthy S, Diaz JV, Slutsky AS, Villar J, Angus DC, Annane D, Azevedo LCP, Berwanger O, Cavalcanti AB, Dequin PF, Du B, Emberson J, Fisher D, Giraudeau B, Gordon AC, Granholm A, Green C, Haynes R, Heming N, Higgins JPT, Horby P, Juni P, Landray MJ, Le Gouge A, Leclerc M, Lim WS, Machado FR, McArthur C, Meziani F, Moller MH, Perner A, Petersen MW, Savovic J, Tomazini B, Veiga VC, Webb S, Marshall JC. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. JAMA. 2020 Oct 6;324(13):1330-1341. doi: 10.1001/jama.2020.17023.
PubMed 32876694Stern A, Skalsky K, Avni T, Carrara E, Leibovici L, Paul M. Corticosteroids for pneumonia. Cochrane Database Syst Rev. 2017 Dec 13;12(12):CD007720. doi: 10.1002/14651858.CD007720.pub3.
PubMed 29236286Blum CA, Nigro N, Briel M, Schuetz P, Ullmer E, Suter-Widmer I, Winzeler B, Bingisser R, Elsaesser H, Drozdov D, Arici B, Urwyler SA, Refardt J, Tarr P, Wirz S, Thomann R, Baumgartner C, Duplain H, Burki D, Zimmerli W, Rodondi N, Mueller B, Christ-Crain M. Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2015 Apr 18;385(9977):1511-8. doi: 10.1016/S0140-6736(14)62447-8. Epub 2015 Jan 19.
PubMed 25608756Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P, Puccio G, Della Porta R, Giorgio C, Blasi F, Umberger R, Meduri GU. Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005 Feb 1;171(3):242-8. doi: 10.1164/rccm.200406-808OC. Epub 2004 Nov 19.
PubMed 15557131Harris LK, Crannage AJ. Corticosteroids in Community-Acquired Pneumonia: A Review of Current Literature. J Pharm Technol. 2021 Jun;37(3):152-160. doi: 10.1177/8755122521995587. Epub 2021 Feb 22.
PubMed 34752553Fernandez-Serrano S, Dorca J, Garcia-Vidal C, Fernandez-Sabe N, Carratala J, Fernandez-Aguera A, Corominas M, Padrones S, Gudiol F, Manresa F. Effect of corticosteroids on the clinical course of community-acquired pneumonia: a randomized controlled trial. Crit Care. 2011 Mar 15;15(2):R96. doi: 10.1186/cc10103.
PubMed 21406101Meijvis SC, Hardeman H, Remmelts HH, Heijligenberg R, Rijkers GT, van Velzen-Blad H, Voorn GP, van de Garde EM, Endeman H, Grutters JC, Bos WJ, Biesma DH. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.
PubMed 21636122Mikami K, Suzuki M, Kitagawa H, Kawakami M, Hirota N, Yamaguchi H, Narumoto O, Kichikawa Y, Kawai M, Tashimo H, Arai H, Horiuchi T, Sakamoto Y. Efficacy of corticosteroids in the treatment of community-acquired pneumonia requiring hospitalization. Lung. 2007 Sep-Oct;185(5):249-255. doi: 10.1007/s00408-007-9020-3. Epub 2007 Aug 21.
PubMed 17710485Snijders D, Daniels JM, de Graaff CS, van der Werf TS, Boersma WG. Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial. Am J Respir Crit Care Med. 2010 May 1;181(9):975-82. doi: 10.1164/rccm.200905-0808OC. Epub 2010 Feb 4.
PubMed 20133929
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
- ClinicalTrials.gov ID
- NCT05354778
- Acronym / sponsor ID
- HYDRO-SHIP / 54214821.0.1001.0068
- Keywords
- Hydrocortisone, Intensive Care Unit, Pneumonia, Steroids, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao PauloUniversity, hospital or other
- Collaborators
- Instituto do Cancer do Estado de São Paulo, Hospital de Câncer de Barretos, University of Sao Paulo
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction and Objectives: the use of corticosteroids in patients with severe community pneumonia reduces morbimortality. However, to our knowledge, there are no studies with steroids for patients in intensive care with nosocomial pneumonia, among which those with ventilator associated pneumonia, infections which carry a high mortality rate. The treatment for those diseases involves intensive care and antibiotics, but there is a need for inexpensive, adjuvant therapies which improve the outcome for those patients. Therefore, the objective of this study is to compare hydrocortisone versus placebo, both with standard therapy, in the outcome of critical care patients diagnosed with nosocomial pneumonia. Methods: multicenter randomized, open-label, controlled trial, with two parallel groups: hydrocortisone or placebo, associated with nosocomial pneumonia's standard treatment. Patients with viral or other etiologies of pneumonia are excluded, as well as corticosteroids chronical users, or patients with conditions which demand this type of therapy. Intravenous 100mg of hydrocortisone and normal saline (the placebo) are tested every eight hours for five days or until intensive care unit (ICU) discharge or until the patient dies. The sample is 180 patients, 90 in each group, in different ICUs in Brazil. The primary outcome is early clinical failure. The secondary outcomes are survival and mortality in both groups, need for intubation, mechanical ventilation, vasoactive drugs and dialysis, lengths of stay in the hospital and in the ICU, radiological progression and adverse events. Discussion, risks, and benefits: 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. Weighing the benefits and risks of this study, as well as its strengths and potential weaknesses, it is believed that its realization is justified, in addition to bringing important advances in the field of intensive care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, randomized, open-label clinical trial with two parallel groups: hydrocortisone and placebo. Data analyzed as "intention-to-treat".
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNormal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit |
| Hydrocortisone | Active comparator | Drug: HydrocortisoneHydrocortisone 100mg + normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: Solu-CORTEFCorticosteroid | Drug | Hydrocortisone |
| PlaceboAlso: NSNormal saline only | Drug | Placebo |
Primary outcome
Early Clinical Failure
Time frame: Between days 0 and 7 for death; between days 3 and 7 for respiratory or cardiovascular worsening
Composite outcome: Death OR Respiratory worsening OR Cardiovascular worsening
13 secondary outcomes
Survival
Time frame: Days 7 and 28
Respiratory failure
Time frame: 7 days
Septic shock
Time frame: 7 days
Time of mechanical ventilation
Time frame: 7 days
Ventilator parameters (1)
Time frame: 7 days
Ventilator parameters (2)
Time frame: 7 days
Arterial blood gas analysis
Time frame: 7 days
Respiratory condition
Time frame: 7 days
Time of vasoactive drugs use
Time frame: 7 days
Length of stay
Time frame: 28 days
Need for renal substitution therapy
Time frame: 7 days
Radiological worsening
Time frame: 7 days
Adverse effects
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 12186604Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.
- Background: PubMed 18184957Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J; CORTICUS Study Group. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24. doi: 10.1056/NEJMoa071366.
- Background: PubMed 29490185Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
- Background: PubMed 28938253Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers SC, Russell JA, Van den Berghe G. Guidelines for the Diagnosis and Management of Critical Illness-Related Corticosteroid Insufficiency (CIRCI) in Critically Ill Patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Crit Care Med. 2017 Dec;45(12):2078-2088. doi: 10.1097/CCM.0000000000002737.
- Background: PubMed 32678530RECOVERY 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.
- Background: PubMed 32876694WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group; Sterne JAC, Murthy S, Diaz JV, Slutsky AS, Villar J, Angus DC, Annane D, Azevedo LCP, Berwanger O, Cavalcanti AB, Dequin PF, Du B, Emberson J, Fisher D, Giraudeau B, Gordon AC, Granholm A, Green C, Haynes R, Heming N, Higgins JPT, Horby P, Juni P, Landray MJ, Le Gouge A, Leclerc M, Lim WS, Machado FR, McArthur C, Meziani F, Moller MH, Perner A, Petersen MW, Savovic J, Tomazini B, Veiga VC, Webb S, Marshall JC. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. JAMA. 2020 Oct 6;324(13):1330-1341. doi: 10.1001/jama.2020.17023.
- Background: PubMed 29236286Stern A, Skalsky K, Avni T, Carrara E, Leibovici L, Paul M. Corticosteroids for pneumonia. Cochrane Database Syst Rev. 2017 Dec 13;12(12):CD007720. doi: 10.1002/14651858.CD007720.pub3.
- Background: PubMed 25608756Blum CA, Nigro N, Briel M, Schuetz P, Ullmer E, Suter-Widmer I, Winzeler B, Bingisser R, Elsaesser H, Drozdov D, Arici B, Urwyler SA, Refardt J, Tarr P, Wirz S, Thomann R, Baumgartner C, Duplain H, Burki D, Zimmerli W, Rodondi N, Mueller B, Christ-Crain M. Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2015 Apr 18;385(9977):1511-8. doi: 10.1016/S0140-6736(14)62447-8. Epub 2015 Jan 19.
- Background: PubMed 15557131Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P, Puccio G, Della Porta R, Giorgio C, Blasi F, Umberger R, Meduri GU. Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005 Feb 1;171(3):242-8. doi: 10.1164/rccm.200406-808OC. Epub 2004 Nov 19.
- Background: PubMed 34752553Harris LK, Crannage AJ. Corticosteroids in Community-Acquired Pneumonia: A Review of Current Literature. J Pharm Technol. 2021 Jun;37(3):152-160. doi: 10.1177/8755122521995587. Epub 2021 Feb 22.
- Background: PubMed 21406101Fernandez-Serrano S, Dorca J, Garcia-Vidal C, Fernandez-Sabe N, Carratala J, Fernandez-Aguera A, Corominas M, Padrones S, Gudiol F, Manresa F. Effect of corticosteroids on the clinical course of community-acquired pneumonia: a randomized controlled trial. Crit Care. 2011 Mar 15;15(2):R96. doi: 10.1186/cc10103.
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VAP - Ventilator Associated Pneumonia
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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Manoel Silva Junior, MD principal investigator
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone in people with Healthcare-Associated Pneumonia and Ventilator Associated Pneumonia, run by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Clinical Failure (time frame: Between days 0 and 7 for death; between days 3 and 7 for respiratory or cardiovascular worsening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05354778, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.