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Completed

NCT Number: NCT00170196

Efficacy Studies of Corticosteroid Therapy in Community-Acquired Pneumonia

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medisch Centrum Alkmaar

Alkmaar, North Holland, 1815 JD, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

Primary outcomes

  1. Clinical efficacy at the end of treatment

Secondary outcomes

  1. Clinical efficacy at follow up

  2. Inflammation response (serummarkers)

  3. Length of Stay

  4. Time to clinical stability

  5. Mortality

  6. Time to defeverescence

Sponsors and collaborators

Lead sponsor

Medical Center Alkmaar

Other

Registry information

Official study title

The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Sep 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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