Community Acquired Pneumonia (CAP)
Conditions
Brief summary
The goal of this cluster randomized controlled trial is to determine the optimal treatment for community aquired pneumonia (CAP). The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 18 years old diagnosed with severe CAP. The main question is whether there is a difference in all cause mortality within thirty days. Participants will be randomized to receive treatment with either hydrocortisone or prednisolone.
Interventions
ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.
DRUGhydrocortisone
ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.
Sponsors
Copenhagen Respiratory Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The study is a cluster randomized controlled trial. It consists of two arms, in which patients will be randomized to receive treatment with either Hydrocortisone or Prednisolone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.
Exclusion criteria
* Admitted \>24 h * Pregnant or breastfeeding women * Active tuberculosis or fungal infection * Pneumonia caused by influenza * Intolerance to either study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 90 days | — |
| All-cause infections | 90 days | — |
| Need for vasopressor treatment | 30 days | — |
| Need for mechanical ventilation | 30 days | — |
| Admission to ICU | 30 days | — |
| Daily amount of insulin administered to the patient by day 7 or discharge from hospital | 7 days | — |
| Gastrointestinal bleeding | 30 days | — |
| Blood glucose levels | 7 days | Measured at day 3 and day 7. |
Countries
Denmark
Contacts
CONTACTJens-Ulrik Stæhr Jensen, MD, PHD
CONTACTPradeesh Sivapalan, MD, PHD
STUDY_DIRECTORJens-Ulrik Stæhr Jensen, MD, PHD
COP:RESP
Outcome results
None listed