Community-Acquired PneumoniaPhase 4NCT00908713
Corticoids in Severe Community-Acquired Pneumonia (CAP)
A Phase 4 study testing methylprednisolone in people with Community-Acquired Pneumonia, run by Hospital Clinic of Barcelona at 3 sites in Spain.
Trial summary
The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2004to Mar 2012
- 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
- Severe community-acquired pneumonia Fine V
- CRP >=15 mg/100 mL
Who cannot join
- Major contraindications for corticosteroids, such as uncontrolled diabetes, immunosuppression
- Previous glucocorticoid treatment during the previous month
- Documented extrapulmonary infection
- Previous hospitalization in the previous month
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Servei Pneumologia. Hospital Clinic
Barcelona, Catalonia, 08036
Servei Pneumoloiga. Hospital Clinic
Barcelona, Catalonia, 08036
Hospital Clinic
Barcelona, 08036
About this study
Official title: Corticoids in Severe Community-acquired Pneumonia
The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.
Read the detailed description
Community acquired pneumonia (CAP) is associated with a local and systemic inflammatory response conducted by different pro and counter inflammatory cytokines. The evolution of the infection is mainly dependent on the intensity of the inflammatory response. The AIM of the project is to determine the clinical usefulness of methylprednisolone treatment (0,5 mg/ Kg weight every 12h for 5 days in patients with severe CAP and an excessive inflammatory response( patients identified based on a cut-off point of the reactive C protein (RCP) of 15 mg/dl). A randomized double blind placebo controlled study with two arms will be performed: The study group (patients with excessive inflammatory response) will receive methylprednisolone + antibiotics. Control group will receive placebo + antibiotics. Patients older than 18 years with Fine V pneumonia will be recruited. Clinical data and prognostic factors (APACHE II and, SOFA scores, etiology, mortality at ICU and at 28 days) will be collected.
- Conditions
- Community-Acquired Pneumonia
- Being tested
- methylprednisolone, Placebo
- Keywords
- Severe CAP, Adjuvant therapy, Glucocorticoids, CAP Fine V with C-reactive protein >= 15 mg/100 mL
- 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 solumoderin
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
PlaceboDrug
Also called sodium chloride
Sodium chloride 0.9% 10 mL every 12 h for 5 days
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Experimental | methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days Receives: Drug: methylprednisolone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-response to empiric antimicrobial treatment
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJan 2004
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Agusti, Hospital Clinic of Barcelona
- Investigators
- Carlos Agusti, MD, Principal investigator, Hospital Clinic, Barcelona,Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908713
- Sponsor's protocol ID
- FIS 2003-CA
- Status last verified
- Mar 2013
- First submitted
- 26 May 2009
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ceccato A, Cilloniz C, Ranzani OT, Menendez R, Agusti C, Gabarrus A, Ferrer M, Sibila O, Niederman MS, Torres A. Treatment with macrolides and glucocorticosteroids in severe community-acquired pneumonia: A post-hoc exploratory analysis of a randomized controlled trial. PLoS One. 2017 Jun 15;12(6):e0178022. doi: 10.1371/journal.pone.0178022. eCollection 2017.
PubMed 28617807Torres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrus A, Sellares J, Restrepo MI, Anzueto A, Niederman MS, Agusti C. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):677-86. doi: 10.1001/jama.2015.88.
PubMed 25688779
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticoids in Severe Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT00908713
- Acronym / sponsor ID
- FIS 2003-CA
- Conditions
- Community-Acquired Pneumonia
- Keywords
- Severe CAP, Adjuvant therapy, Glucocorticoids, CAP Fine V with C-reactive protein >= 15 mg/100 mL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 May 2009 (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 this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.
Detailed description
Community acquired pneumonia (CAP) is associated with a local and systemic inflammatory response conducted by different pro and counter inflammatory cytokines. The evolution of the infection is mainly dependent on the intensity of the inflammatory response. The AIM of the project is to determine the clinical usefulness of methylprednisolone treatment (0,5 mg/ Kg weight every 12h for 5 days in patients with severe CAP and an excessive inflammatory response( patients identified based on a cut-off point of the reactive C protein (RCP) of 15 mg/dl). A randomized double blind placebo controlled study with two arms will be performed: The study group (patients with excessive inflammatory response) will receive methylprednisolone + antibiotics. Control group will receive placebo + antibiotics. Patients older than 18 years with Fine V pneumonia will be recruited. Clinical data and prognostic factors (APACHE II and, SOFA scores, etiology, mortality at ICU and at 28 days) will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Experimental | Drug: methylprednisolonemethylprednisolone 0.5 mg/kg body weight every 12 h for 5 days |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe community-acquired pneumonia Fine V
- CRP >=15 mg/100 mL
Key exclusion criteria (4 listed)
- Major contraindications for corticosteroids, such as uncontrolled diabetes, immunosuppression
- Previous glucocorticoid treatment during the previous month
- Documented extrapulmonary infection
- Previous hospitalization in the previous month
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: solumoderinmethylprednisolone 0.5 mg/kg body weight every 12 h for 5 days | Drug | methylprednisolone |
| PlaceboAlso: sodium chlorideSodium chloride 0.9% 10 mL every 12 h for 5 days | Drug | Placebo |
Primary outcome
Rate of non-response to empiric antimicrobial treatment
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Derived from this study: PubMed 28617807Ceccato A, Cilloniz C, Ranzani OT, Menendez R, Agusti C, Gabarrus A, Ferrer M, Sibila O, Niederman MS, Torres A. Treatment with macrolides and glucocorticosteroids in severe community-acquired pneumonia: A post-hoc exploratory analysis of a randomized controlled trial. PLoS One. 2017 Jun 15;12(6):e0178022. doi: 10.1371/journal.pone.0178022. eCollection 2017.
- Derived from this study: PubMed 25688779Torres A, Sibila O, Ferrer M, Polverino E, Menendez R, Mensa J, Gabarrus A, Sellares J, Restrepo MI, Anzueto A, Niederman MS, Agusti C. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):677-86. doi: 10.1001/jama.2015.88.
- Related InfoLink provided by the sponsor.
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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.
Carlos Agusti, MD principal investigator
Hospital Clinic, Barcelona,Spain.
3 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 in people with Community-Acquired Pneumonia, run by Hospital Clinic of Barcelona at 3 sites in Spain.
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 4 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: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of non-response to empiric antimicrobial treatment (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00908713, which also lists 2 linked publications.
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 20 Mar 2013.