PneumoniaOvidiusNCT00471640
Dexamethasone Infusion in Community-acquired Pneumonia
A study testing dexamethasone in people with Pneumonia, run by St. Antonius Hospital at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2007to Sep 2010
- Phase
- Interventional
- 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
- Patients aged 18 to 100 years with a community-acquired pneumonia.
- Criteria to determine a community-acquired pneumonia:
- Chest radiograph showing new opacities
- In combination with two of the following findings:
- Cough
- Production of sputum
Show all 10Show fewer
- Temp >38,0 °C or <36,0 °C
- Audible abnormalities by chest examination compatible with pneumonia
- Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leukopenia (<4000 cells/mm3)
- CRP > 15 mg/dl (three times upper limit of normal)
Who cannot join
- o The following groups are excluded:
- Immunocompromised patients:
- Patients with a known congenital or achieved immunodeficiency.
- Patients who received chemotherapy less than 6 weeks ago.
- Patients who received corticosteroids in the last 6 weeks.
- Patients who received immunosuppressive medication in the last 6 weeks. (like cyclosporine, cyclofosfamide, azathioprine)
- Patients with COPD who are on systemic corticosteroids for COPD.
- Patients who require ICU treatment.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Gelderse Vallei Ede
Ede, Gelderland
St Antonius Hosptial
Nieuwegein, Utrecht, 3430 EM
About this study
The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.
Read the detailed description
Community-acquired pneumonia (CAP) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring ICU admission.1 Especially elderly patients may have a severe illness with a high morbidity and mortality rate. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. However, this natural reaction can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung.
Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Hypothetically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).
- Conditions
- Pneumonia
- Being tested
- dexamethasone
- Keywords
- pneumonia, dexamethasone, community-acquired pneumonia
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
4 days 5 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | dexamethasone Receives: Drug: dexamethasone |
| 2 | Placebo comparator | Placebo Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
Measured: 30 days
Secondary outcomes (1)
side-effects inflammation markers lung function
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 posted10 May 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Investigators
- D Biesma, dr., Study director, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471640
- Sponsor's protocol ID
- versie 1
- Acronym
- Ovidius
- Status last verified
- Sep 2010
- First submitted
- 8 May 2007
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raeven VM, Spoorenberg SM, Boersma WG, van de Garde EM, Cannegieter SC, Voorn GP, Bos WJ, van Steenbergen JE; Alkmaar study group; Ovidius study group. Atypical aetiology in patients hospitalised with community-acquired pneumonia is associated with age, gender and season; a data-analysis on four Dutch cohorts. BMC Infect Dis. 2016 Jun 17;16:299. doi: 10.1186/s12879-016-1641-9.
PubMed 27317257Remmelts HH, van de Garde EM, Meijvis SC, Peelen EL, Damoiseaux JG, Grutters JC, Biesma DH, Bos WJ, Rijkers GT. Addition of vitamin D status to prognostic scores improves the prediction of outcome in community-acquired pneumonia. Clin Infect Dis. 2012 Dec;55(11):1488-94. doi: 10.1093/cid/cis751. Epub 2012 Aug 31.
PubMed 22942205Meijvis SC, Hardeman H, Remmelts HH, Heijligenberg R, Rijkers GT, van Velzen-Blad H, Voorn GP, van de Garde EM, Endeman H, Grutters JC, Bos WJ, Biesma DH. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.
PubMed 21636122
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Infusion in Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT00471640
- Acronym / sponsor ID
- Ovidius / versie 1
- Conditions
- Pneumonia
- Keywords
- pneumonia, dexamethasone, community-acquired pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 May 2007 (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 determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.
Detailed description
Community-acquired pneumonia (CAP) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring ICU admission.1 Especially elderly patients may have a severe illness with a high morbidity and mortality rate. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. However, this natural reaction can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung.
Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Hypothetically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).
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 |
|---|---|---|
| 1 | Active comparator | Drug: dexamethasonedexamethasone |
| 2 | Placebo comparator | Drug: dexamethasonePlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 to 100 years with a community-acquired pneumonia.
- Chest radiograph showing new opacities
- In combination with two of the following findings:
Key exclusion criteria (8 listed)
- o The following groups are excluded:
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 |
|---|---|---|
| dexamethasone4 days 5 mg | Drug | 1, 2 |
Primary outcome
length of hospital stay
Time frame: 30 days
1 secondary outcome
side-effects inflammation markers lung function
Time frame: 30 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 27 Sep 2010.
- Derived from this study: PubMed 27317257Raeven VM, Spoorenberg SM, Boersma WG, van de Garde EM, Cannegieter SC, Voorn GP, Bos WJ, van Steenbergen JE; Alkmaar study group; Ovidius study group. Atypical aetiology in patients hospitalised with community-acquired pneumonia is associated with age, gender and season; a data-analysis on four Dutch cohorts. BMC Infect Dis. 2016 Jun 17;16:299. doi: 10.1186/s12879-016-1641-9.
- Derived from this study: PubMed 22942205Remmelts HH, van de Garde EM, Meijvis SC, Peelen EL, Damoiseaux JG, Grutters JC, Biesma DH, Bos WJ, Rijkers GT. Addition of vitamin D status to prognostic scores improves the prediction of outcome in community-acquired pneumonia. Clin Infect Dis. 2012 Dec;55(11):1488-94. doi: 10.1093/cid/cis751. Epub 2012 Aug 31.
- Derived from this study: PubMed 21636122Meijvis SC, Hardeman H, Remmelts HH, Heijligenberg R, Rijkers GT, van Velzen-Blad H, Voorn GP, van de Garde EM, Endeman H, Grutters JC, Bos WJ, Biesma DH. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
D Biesma, dr. study director
St. Antonius Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexamethasone in people with Pneumonia, run by St. Antonius Hospital at 2 sites in Netherlands.
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 10 inclusion and 8 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 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
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?
length of hospital stay (time frame: 30 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 NCT00471640, which also lists 3 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 27 Sep 2010.