Clinical trial NCT00170196: Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia
Official title: The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: pneumonia
corticosteroids
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical efficacy at the end of treatment
Secondary outcomes:
measure: Clinical efficacy at follow up
measure: Inflammation response (serummarkers)
measure: Length of Stay
measure: Time to clinical stability
measure: Mortality
measure: Time to defeverescence
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
state: Noord-Holland
Study officials:
affiliation: Pulmo Science
name: Dominic Snijders, Drs
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmo Science
name: Wim G Boersma, dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.