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Completed

NCT Number: NCT00973154

Corticosteroid Treatment for Community-Acquired Pneumonia - 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Klinik, Kantonsspital Liestal, Liestal, Basel-Landschaft, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

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

Primary outcomes

  1. Time to clinical stability

    Time frame: 30 days

Secondary outcomes

  1. Side effects of corticosteroids, mortality, recurrence

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Kantonsspital Aarau
  • Kantonsspital Liestal

Registry information

Official study title

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

Acronym: STEP

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2009
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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