Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in patient admitted with Community-acquired pneumonia.

The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with CAP.

Detailed Description

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Community-acquired pneumonia (CAP) is a acute illness with a considerable morbidity and mortality, especially patients with severe CAP. In the past decennia, in spite of many investigations, little reduction is seen in morbidity an mortality. Corticosteroids have a immune-modulation effect, which is not completely elucidated. Most likely the immune modulation effect is due to down-regulation of pro-inflammatory cytokines. The use of corticosteroids next to antibiotics in CAP could lead to shorter time to clinical stability, length of stay and costs.

Comparison: Hospitalized patients with CAP treated with antibiotics and prednisolone versus hospitalized patients with cap treated with antibiotics and placebo

Conditions

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Pneumonia

Keywords

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pneumonia corticosteroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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prednisone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Clinical symptoms of community-acquired pneumonia:

* Fever, cough, sputum, pleural pain, dyspnoea
* Radiological symptoms of pneumoniä

Exclusion Criteria

* Any conditions wich requires corticosteroid therapy.
* Pregnancy of lactation
* Malignancy
* Immune-compromised patients (eg chemotherapy or AIDS)
* Pre-treatment with macrolide for \>24 hours

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Dominic Snijders, Drs

Role: PRINCIPAL_INVESTIGATOR

Pulmo Science

Wim G Boersma, dr

Role: STUDY_DIRECTOR

Pulmo Science

Locations

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Medisch Centrum Alkmaar

Alkmaar, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Raeven VM, Spoorenberg SM, Boersma WG, van de Garde EM, Cannegieter SC, Voorn GP, Bos WJ, van Steenbergen JE; Alkmaar study group; Ovidius study group. Atypical aetiology in patients hospitalised with community-acquired pneumonia is associated with age, gender and season; a data-analysis on four Dutch cohorts. BMC Infect Dis. 2016 Jun 17;16:299. doi: 10.1186/s12879-016-1641-9.

Reference Type DERIVED

PMID: 27317257 (View on PubMed)

Snijders D, Daniels JM, de Graaff CS, van der Werf TS, Boersma WG. Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial. Am J Respir Crit Care Med. 2010 May 1;181(9):975-82. doi: 10.1164/rccm.200905-0808OC. Epub 2010 Feb 4.