Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Community-acquired Pneumonia Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973154
• Other study ID #: STEP
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2009
• Last updated: April 20, 2015
• Start date: December 2009
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Prednisone
50mg per day of prednisone orally for 7 days versus placebo

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	University Hospital Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	Bruderholzspital	Bruderholz
Switzerland	Medicine Interne, Hôpital du Jura, site de Delémont	Delémont	JU
Switzerland	Medizinische Klinik, Kantonsspital Liestal	Liestal	BL
Switzerland	Bürgerspital	Solothurn

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Kantonsspital Aarau, Kantonsspital Liestal

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical stability		30 days	Yes
Secondary	Side effects of corticosteroids, mortality, recurrence		30 days	Yes