Community Acquired Pneumonia (CAP)Phase 4NCT06892197
Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)
A Phase 4 study testing Methylprednisolone (drug) and hydrocortisone in people with Community Acquired Pneumonia (CAP), run by Copenhagen Respiratory Research at 14 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia (CAP)
- What is being tested?
- Methylprednisolone (drug) and hydrocortisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 14 sitesDenmark
- Study dates
- 10 Mar 2026to 1 Nov 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.
Who cannot join
- Admitted >24 h
- Pregnant or breastfeeding women
- Active tuberculosis or fungal infection
- Pneumonia caused by influenza
- Intolerance to either study drug
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Denmark14 sites, 14 recruiting
- Recruiting
Amager Hospital
Copenhagen, Copenhagen City, 2300
- Recruiting
Bispebjerg Hospital
Copenhagen, Copenhagen City, 2400
- Recruiting
Frederiksberg Hospital
Frederiksberg, Copenhagen City, 2000
- Recruiting
Gentofte Hospital
Hellerup, Copenhagen City, 2900
- Recruiting
Herlev Hospital
Herlev, Copnhagen Surroundings, 2730
- Recruiting
Nordsjællands Hospital
Hillerød, North Zealand, 3400
- Recruiting
Holbæk Sygehus
Holbæk, Region Sjælland, 4300
- Recruiting
Hvidovre Hospital
Hvidovre, Copnhagen Surroundings, 2650
- Recruiting
University Hospital of Region Zealand, Køge
Køge, Region Sjælland, 4600
- Recruiting
Næstved Sygehus
Næstved, Region Sjælland, 4700
- Recruiting
Ringsted Sygehus
Ringsted, Region Sjælland, 4100
- Recruiting
Bornholm Hospital
Rønne, Bornholm, 3700
- Recruiting
University Hospital of Region Zealand, Roskilde
Roskilde, Region Sjælland, 4000
- Recruiting
Slagelse Sygehus
Slagelse, Region Sjælland, 4200
About this study
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.
- Conditions
- Community Acquired Pneumonia (CAP)
- Being tested
- Methylprednisolone (drug), hydrocortisone
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone (drug)Drug
ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.
hydrocortisoneDrug
ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Hydrocortisone. | Active comparator | This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days. Receives: Drug: hydrocortisone |
| Treatment with Methylprednisolone | Active comparator | This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days. Receives: Drug: Methylprednisolone (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 30 days
Secondary outcomes (8)
All-cause mortality
Measured: 90 days
All-cause infections
Measured: 90 days
Need for vasopressor treatment
Measured: 30 days
Need for mechanical ventilation
Measured: 30 days
Admission to ICU
Measured: 30 days
Daily amount of insulin administered to the patient by day 7 or discharge from hospital
Measured: 7 days
Gastrointestinal bleeding
Measured: 30 days
Blood glucose levels
Measured at day 3 and day 7.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start10 Mar 2026
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Respiratory Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens-Ulrik Stæhr Jensen, MD, PHD, Study director, COP:RESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892197
- Sponsor's protocol ID
- MineraloCAP
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This has not yet been decided.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)
- ClinicalTrials.gov ID
- NCT06892197
- Acronym / sponsor ID
- MineraloCAP
- Conditions
- Community Acquired Pneumonia (CAP)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Copenhagen Respiratory ResearchResearch network
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Hydrocortisone. | Active comparator | Drug: hydrocortisoneThis arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days. |
| Treatment with Methylprednisolone | Active comparator | Drug: Methylprednisolone (drug)This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.
Key exclusion criteria (5 listed)
- Admitted >24 h
- Pregnant or breastfeeding women
- Active tuberculosis or fungal infection
- Pneumonia caused by influenza
- Intolerance to either study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone (drug)ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally. | Drug | Treatment with Methylprednisolone |
| hydrocortisoneATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate. | Drug | Treatment with Hydrocortisone. |
Primary outcome
All-cause mortality
Time frame: 30 days
8 secondary outcomes
All-cause mortality
Time frame: 90 days
All-cause infections
Time frame: 90 days
Need for vasopressor treatment
Time frame: 30 days
Need for mechanical ventilation
Time frame: 30 days
Admission to ICU
Time frame: 30 days
Daily amount of insulin administered to the patient by day 7 or discharge from hospital
Time frame: 7 days
Gastrointestinal bleeding
Time frame: 30 days
Blood glucose levels
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided. This has not yet been decided.
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Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
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Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens-Ulrik Stæhr Jensen, MD, PHD study director
COP:RESP
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone (drug) and hydrocortisone in people with Community Acquired Pneumonia (CAP), run by Copenhagen Respiratory Research at 14 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens-Ulrik Stæhr Jensen, MD, PHD (38673057 ext. +45, jens.ulrik.jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.