- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00973154
Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial (STEP)
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.
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Aarau, Sveits
- Kantonsspital Aarau
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Basel, Sveits, 4031
- University Hospital Basel
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Bern, Sveits
- Inselspital
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Bruderholz, Sveits
- Bruderholzspital
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Solothurn, Sveits
- Bürgerspital
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BL
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Liestal, BL, Sveits, 4410
- Medizinische Klinik, Kantonsspital Liestal
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JU
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Delémont, JU, Sveits, 2800
- Medicine Interne, Hôpital du Jura, site de Delémont
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
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50mg per day of prednisone orally for 7 days versus placebo
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Aktiv komparator: Prednisone
Drug
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50mg per day of prednisone orally for 7 days versus placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time to clinical stability
Tidsramme: 30 days
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30 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Side effects of corticosteroids, mortality, recurrence
Tidsramme: 30 days
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30 days
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mirjam Christ-Crain, MD, University Hospital, Basel, Switzerland
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STEP
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