Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Hydrocortisone. | Active Comparator | This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days. |
|
| Treatment with Methylprednisolone | Active Comparator | This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone (drug) | Drug | ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 90 days | |
| All-cause infections | 90 days | |
| Need for vasopressor treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens-Ulrik Stæhr Jensen, MD, PHD | Contact | 38673057 | +45 | jens.ulrik.jensen@regionh.dk |
| Pradeesh Sivapalan, MD, PHD | Contact | 29880601 | +45 | pradeesh.sivapalan.02@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jens-Ulrik Stæhr Jensen, MD, PHD | COP:RESP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bornholm Hospital | Recruiting | Rønne | Bornholm | 3700 | Denmark | |
| Amager Hospital |
This has not yet been decided.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| hydrocortisone | Drug | ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate. |
|
| 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 | Measured at day 3 and day 7. | 7 days |
| Recruiting |
| Copenhagen |
| Copenhagen City |
| 2300 |
| Denmark |
| Bispebjerg Hospital | Recruiting | Copenhagen | Copenhagen City | 2400 | Denmark |
| Frederiksberg Hospital | Recruiting | Frederiksberg | Copenhagen City | 2000 | Denmark |
| Gentofte Hospital | Recruiting | Hellerup | Copenhagen City | 2900 | Denmark |
| Herlev Hospital | Recruiting | Herlev | Copnhagen Surroundings | 2730 | Denmark |
| Hvidovre Hospital | Recruiting | Hvidovre | Copnhagen Surroundings | 2650 | Denmark |
| Nordsjællands Hospital | Recruiting | Hillerød | North Zealand | 3400 | Denmark |
| Holbæk Sygehus | Recruiting | Holbæk | Region Sjælland | 4300 | Denmark |
| University Hospital of Region Zealand, Køge | Recruiting | Køge | Region Sjælland | 4600 | Denmark |
| Næstved Sygehus | Recruiting | Næstved | Region Sjælland | 4700 | Denmark |
| Ringsted Sygehus | Recruiting | Ringsted | Region Sjælland | 4100 | Denmark |
| University Hospital of Region Zealand, Roskilde | Recruiting | Roskilde | Region Sjælland | 4000 | Denmark |
| Slagelse Sygehus | Recruiting | Slagelse | Region Sjælland | 4200 | Denmark |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D004364 | Pharmaceutical Preparations |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
Not provided
Not provided