Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Phase 3

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Prednisone

• Registration Number: NCT00973154
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-09-07
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Study Start: 2009-12
• Status Verified: 2014-05
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone	Prednisone	Drug
Placebo	Prednisone	-

Primary Outcome Measures

Name	Time	Method
Time to clinical stability	30 days

Secondary Outcome Measures

Name	Time	Method
Side effects of corticosteroids, mortality, recurrence	30 days

Trial Locations

Locations (7)

Bruderholzspital; 🇨🇭 Bruderholz, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland

Medizinische Klinik, Kantonsspital Liestal; 🇨🇭 Liestal, BL, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Medicine Interne, Hôpital du Jura, site de Delémont; 🇨🇭 Delémont, JU, Switzerland

Bürgerspital; 🇨🇭 Solothurn, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland