AzTrials
AzTrials

Community-acquired PneumoniaPhase 3STEPNCT00973154

Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

A Phase 3 study testing Prednisone in people with Community-acquired Pneumonia, run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: An intact hypothalami-pituitary-adrenal (HPA) axis with an effective intracellular anti-inflammatory activity of glucocorticoids is indispensable for host survival during stress upon exposure to an infectious agent. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community-acquired Pneumonia
What is being tested?
Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
7 sitesSwitzerland
Study dates
Dec 2009to Dec 2014
Phase
Phase 3
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

  • Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP.
  • CAP will be defined by a new infiltrate on chest radiograph and the presence of one or several of the following acute respiratory signs or symptoms:
  • cough
  • sputum production
  • dyspnea
  • core body temperature >38.0° C
  • auscultatory findings of abnormal breath sounds and rales
  • leukocyte count >10 or <4 x 109 cells L-1 (1)

Who cannot join

  • Patients or family members unable to give written informed consent, e.g. with severe dementia.
  • Patients with active intravenous drug use.
  • Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count < 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values < 500 x 109/L); patients with cystic fibrosis as well as patients with active tuberculosis.
  • Patients with acute burn injury
  • Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization
  • Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent
  • Pregnancy or breast feeding
  • Patients with known adrenal insufficiency

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Switzerland7 sites

  • Kantonsspital Aarau

    Aarau

  • University Hospital Basel

    Basel, 4031

  • Inselspital

    Bern

  • Bruderholzspital

    Bruderholz

  • Medicine Interne, Hôpital du Jura, site de Delémont

    Delémont, Canton of Jura, 2800

  • Medizinische Klinik, Kantonsspital Liestal

    Liestal, Basel-Landschaft, 4410

  • Bürgerspital

    Solothurn

Other trials in Switzerland

About this study

Official title: Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial

Background: An intact hypothalami-pituitary-adrenal (HPA) axis with an effective intracellular anti-inflammatory activity of glucocorticoids is indispensable for host survival during stress upon exposure to an infectious agent. Community-acquired pneumonia (CAP) is characterized by significant mortality and increased circulating inflammatory cytokines. Despite adequate antimicrobial therapy mortality rates for CAP have not changed over several decades. The use of corticosteroids in patients with CAP is inconclusive.

Study aim: To compare a 7 days treatment with prednisone and placebo in patients with community-acquired pneumonia with respect to time to clinical stability.

Read more

Study hypothesis: The investigators hypothesize that use of corticosteroids will lead to a 25% relative risk reduction for death and clinical instability.

Study type: randomized double blind intervention study

Patients: 800 patients with community-acquired pneumonia

Being tested
Prednisone
Keywords
Pneumonia, Corticosteroids, clinical stability
Medical subject headings
Community-Acquired Pneumonia, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoneDrug

    50mg per day of prednisone orally for 7 days versus placebo

Study groups in NCT00973154
Study groupRoleWhat they receive
PrednisoneActive comparatorDrug
Receives: Drug: Prednisone
PlaceboPlacebo comparatorNot described
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to clinical stability

    Measured: 30 days

Secondary outcomes (1)

  1. Side effects of corticosteroids, mortality, recurrence

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionJul 2014
  4. Study completionDec 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00973154
Sponsor's protocol ID
STEP
Acronym
STEP
Status last verified
May 2014
First submitted
7 Sep 2009
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Blum CA, Roethlisberger EA, Cesana-Nigro N, Winzeler B, Rodondi N, Blum MR, Briel M, Mueller B, Christ-Crain M, Schuetz P. Adjunct prednisone in community-acquired pneumonia: 180-day outcome of a multicentre, double-blind, randomized, placebo-controlled trial. BMC Pulm Med. 2023 Dec 11;23(1):500. doi: 10.1186/s12890-023-02794-w.

    PubMed 38082273

  • Borisov AN, Blum CA, Christ-Crain M, Ebrahimi F. No obesity paradox in patients with community-acquired pneumonia - secondary analysis of a randomized controlled trial. Nutr Diabetes. 2022 Mar 23;12(1):12. doi: 10.1038/s41387-022-00190-7.

    PubMed 35322019

  • Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.

    PubMed 33980941

  • Potasso L, Sailer CO, Blum CA, Cesana-Nigro N, Schuetz P, Mueller B, Christ-Crain M. Mild to moderate hyponatremia at discharge is associated with increased risk of recurrence in patients with community-acquired pneumonia. Eur J Intern Med. 2020 May;75:44-49. doi: 10.1016/j.ejim.2019.12.009. Epub 2020 Jan 15.

    PubMed 31952985

  • Popovic M, Cesana-Nigro N, Winzeler B, Thomann R, Schutz P, Muller B, Christ-Crain M, Blum CA. Estimation of treatment allocation in a randomised, double-blinded, placebo-controlled trial. Swiss Med Wkly. 2019 Jul 24;149:w20114. doi: 10.4414/smw.2019.20114. eCollection 2019 Jul 15.

    PubMed 31340056

  • Blum CA, Schuetz P, Nigro N, Winzeler B, Arici B, Refardt J, Urwyler SA, Rodondi N, Blum MR, Briel M, Mueller B, Christ-Crain M. Cosyntropin testing does not predict response to glucocorticoids in community-acquired pneumonia in a randomized controlled trial. Clin Endocrinol (Oxf). 2019 Sep;91(3):374-382. doi: 10.1111/cen.13907. Epub 2019 Jan 9.

    PubMed 30485501

  • Popovic M, Blum CA, Nigro N, Mueller B, Schuetz P, Christ-Crain M. Benefit of adjunct corticosteroids for community-acquired pneumonia in diabetic patients. Diabetologia. 2016 Dec;59(12):2552-2560. doi: 10.1007/s00125-016-4091-4. Epub 2016 Sep 10.

    PubMed 27614658

  • Wirz SA, Blum CA, Schuetz P, Albrich WC, Noppen C, Mueller B, Christ-Crain M, Tarr PE; STEP Study Group. Pathogen- and antibiotic-specific effects of prednisone in community-acquired pneumonia. Eur Respir J. 2016 Oct;48(4):1150-1159. doi: 10.1183/13993003.00474-2016. Epub 2016 Jul 28.

    PubMed 27471201

  • Blum 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 25608756

  • Blum CA, Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Briel M, Bingisser R, Zimmerli W, Ullmer E, Elsaesser H, Tarr P, Wirz S, Thomann R, Hofmann E, Rodondi N, Duplain H, Burki D, Mueller B, Christ-Crain M. Corticosteroid treatment for community-acquired pneumonia--the STEP trial: study protocol for a randomized controlled trial. Trials. 2014 Jun 28;15:257. doi: 10.1186/1745-6215-15-257.

    PubMed 24974155

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prednisone in people with Community-acquired Pneumonia, run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.

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 8 inclusion and 8 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Switzerland. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Time to clinical stability (time frame: 30 days). 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 NCT00973154, which also lists 10 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 21 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in