Corticosteroid Treatment for Community-Acquired Pneumonia... | NCT00973154

Studies
Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

NCT00973154

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Apr 21, 2015Estimated

Enrollment

800Actual

Phase

Phase 3

Conditions

Community-acquired Pneumonia

Interventions

Prednisone

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jul 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Sep 7, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Name	Class
Kantonsspital Aarau	OTHER
Kantonsspital Liestal	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prednisone	Active Comparator	Drug	Drug: Prednisone
Placebo	Placebo Comparator		Drug: Prednisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisone	Drug	50mg per day of prednisone orally for 7 days versus placebo	Placebo Prednisone

Measure	Description	Time Frame
Time to clinical stability		30 days

Measure	Description	Time Frame
Side effects of corticosteroids, mortality, recurrence		30 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mirjam Christ-Crain, MD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Klinik, Kantonsspital Liestal		Liestal	Basel-Landschaft	4410	Switzerland
Medicine Interne, Hôpital du Jura, site de Delémont

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38082273	Derived	Blum CA, Roethlisberger EA, Cesana-Nigro N, Winzeler B, Rodondi N, Blum MR, Briel M, Mueller B, Christ-Crain M, Schuetz P. Adjunct prednisone in community-acquired pneumonia: 180-day outcome of a multicentre, double-blind, randomized, placebo-controlled trial. BMC Pulm Med. 2023 Dec 11;23(1):500. doi: 10.1186/s12890-023-02794-w.
35322019

ID	Term
D017714	Community-Acquired Infections
D007239	Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

ID	Term
D000098968	Community-Acquired Pneumonia
D011014	Pneumonia