Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT00973154

Collaborator

Kantonsspital Aarau (Other), Kantonsspital Liestal (Other)

800

Enrollment

Locations

Arms

Duration (Months)

114.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia	Drug: Prednisone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prednisone Drug	Drug: Prednisone 50mg per day of prednisone orally for 7 days versus placebo
Placebo Comparator: Placebo	Drug: Prednisone 50mg per day of prednisone orally for 7 days versus placebo

Arm

Intervention/Treatment

Active Comparator: Prednisone

Drug

Drug: Prednisone

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

Placebo Comparator: Placebo

Drug: Prednisone

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

Outcome Measures

Primary Outcome Measures

Time to clinical stability [30 days]

Secondary Outcome Measures

Side effects of corticosteroids, mortality, recurrence [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Klinik, Kantonsspital Liestal	Liestal	BL	Switzerland	4410
2	Medicine Interne, Hôpital du Jura, site de Delémont	Delémont	JU	Switzerland	2800
3	Kantonsspital Aarau	Aarau		Switzerland
4	University Hospital Basel	Basel		Switzerland	4031
5	Inselspital	Bern		Switzerland
6	Bruderholzspital	Bruderholz		Switzerland
7	Bürgerspital	Solothurn		Switzerland