Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Conditions

Community-acquired Pneumonia

Keywords

Pneumonia, Corticosteroids, clinical stability

Brief 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. 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

Blum CA, Roethlisberger EA, Cesana-Nigro N, Winzeler B, Rodondi N, Blum MR, Briel M, Mueller B, Christ-Crain M, Schuetz P.

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Popovic M, Blum CA, Nigro N, Mueller B, Schuetz P, Christ-Crain M.

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Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial.

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.

2015-01-19270 citations

10.1016/s0140-6736(14)62447-8

Corticosteroid treatment for community-acquired pneumonia - the STEP trial: study protocol for a randomized controlled trial

C Blum, N Nigro, Bettina Winzeler, Isabelle Suter‐Widmer, Philipp Schüetz et al. (19 authors)

Trials2014-06-2819 citations

10.1186/1745-6215-15-257

Interventions

DRUGPrednisone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP. 2. 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

1. Patients or family members unable to give written informed consent, e.g. with severe dementia. 2. Patients with active intravenous drug use. 3. 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. 4. Patients with acute burn injury 5. Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization 6. Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent 7. Pregnancy or breast feeding 8. Patients with known adrenal insufficiency

Design outcomes

Primary

Measure	Time frame
Time to clinical stability	30 days

Secondary

Measure	Time frame
Side effects of corticosteroids, mortality, recurrence	30 days

Countries

Switzerland

Outcome results

None listed