Community Acquired PneumoniaPhase 4NCT02552342
Corticosteroid Therapy for Severe Community-Acquired Pneumonia
A Phase 4 study testing methylprednisolone and Normal saline in people with Community Acquired Pneumonia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of the present study is to assess the efficacy of methylprednisolone as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5). The hypothesis of the study is that methylprednisolone can decrease the mortality of severe CAP without any significant side effects,with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- methylprednisolone and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- May 2015to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- community-acquired pneumonia
- PSI score：4-5
- with at least one of following conditions：①CRP ≥150 mg/L,②oxygen index ≤250 , ③bilateral or multi-lober infiltrates in chest image,④ area of pulmonary infiltrates increase >50% with 48 hous,⑤fever higher than 39℃ exceed 72 hours
Who cannot join
- nosocomial Pneumonia
- aspiration pneumonia
- acute burn injury
- gastrointestinal bleeding within the past three months
- uncontrolled diabetes mellitus
- pregnant or breast feeding
Show all 10Show fewer
- a condition requiring treatment with greater than 0.5 mg/kg/d of prednison or its equivalent
- severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
- active tuberculosis
- preexisting medical condition with a life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jun Xu, MD, 01069159142, xujunfree@126.com
Xuezhong Yu, MD, 01069159142, yxzpumch@126.com
About this study
Official title: Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial
The purpose of the present study is to assess the efficacy of methylprednisolone as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).
The hypothesis of the study is that methylprednisolone can decrease the mortality of severe CAP without any significant side effects,with reduction of the time to clinical stability and failure rate of treatment.
- Conditions
- Community Acquired Pneumonia
- Being tested
- methylprednisolone, Normal saline
- 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.
Also called Solu-Medrol
Normal salineDrug
Also called sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Active comparator | This group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days Receives: Drug: methylprednisolone |
| Placebo | Placebo comparator | This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Cangzhou Central Hospital, Cangzhou People's Hospital, Affiliated Hospital of Hebei University, Nantong University, The First Affiliated Hospital of Anhui Medical University, Northern Jiangsu People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Taishan Medical University Affiliated Hospital, Tianjin Third Central Hospital, Jinhua Central Hospital, Navy General Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- Xuezhong Yu, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552342
- Sponsor's protocol ID
- JS-836
- Status last verified
- Sep 2015
- First submitted
- 16 Sep 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02552342
- Acronym / sponsor ID
- JS-836
- Conditions
- Community Acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Cangzhou Central Hospital, Cangzhou People's Hospital, Affiliated Hospital of Hebei University, Nantong University, The First Affiliated Hospital of Anhui Medical University, Northern Jiangsu People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Taishan Medical University Affiliated Hospital, Tianjin Third Central Hospital, Jinhua Central Hospital, Navy General Hospital, Beijing
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- 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 purpose of the present study is to assess the efficacy of methylprednisolone as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).
The hypothesis of the study is that methylprednisolone can decrease the mortality of severe CAP without any significant side effects,with reduction of the time to clinical stability and failure rate of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Active comparator | Drug: methylprednisoloneThis group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days |
| Placebo | Placebo comparator | Drug: Normal salineThis group was meant to receive placebo (sterile normal saline in a volume equal to the study drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- community-acquired pneumonia
- PSI score：4-5
- with at least one of following conditions：①CRP ≥150 mg/L,②oxygen index ≤250 , ③bilateral or multi-lober infiltrates in chest image,④ area of pulmonary infiltrates increase >50% with 48 hous,⑤fever higher than 39℃ exceed 72 hours
Key exclusion criteria (10 listed)
- nosocomial Pneumonia
- aspiration pneumonia
- acute burn injury
- gastrointestinal bleeding within the past three months
- uncontrolled diabetes mellitus
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 |
|---|---|---|
| methylprednisoloneAlso: Solu-Medrol | Drug | methylprednisolone |
| Normal salineAlso: sodium chloride | Drug | Placebo |
Primary outcome
All cause mortality
Time frame: 30-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
Related trials for Community Acquired Pneumonia
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Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
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Local Antibiotic Delivery for 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. This study is not recruiting at the moment.
Xuezhong Yu, MD study director
Peking Union Medical College Hospital
1 site 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 and Normal saline in people with Community Acquired Pneumonia, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun XU, MD (01069159142, xujunfree@126.com), 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 17 Sep 2015.