Community-acquired PneumoniaNCT01631916
Corticosteroids in Community-acquired Pneumonia
A study testing corticosteroid in people with Community-acquired Pneumonia, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
Trial summary
The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in children hospitalized with community-acquired pneumonia. The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteArgentina
- Study dates
- Nov 2015to Mar 2017
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children hospitalized for community-acquired pneumonia
- 2-18 years old
Who cannot join
- Pulmonary chronic disease (including asthma)
- Immunodeficiency
- Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases)
- Wheezing in current disease
- Previous hospitalization (14 days prior to admission)
- Pleural effusion on admission
- Malnutrition
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital General de NIños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., C1270AAN
About this study
Official title: Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia
The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in children hospitalized with community-acquired pneumonia.
The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia.
Read the detailed description
Community-acquired pneumonia (CAP) is a common problem in pediatric practice. The lower respiratory tract infections, particularly pneumonia, are a frequent cause of morbidity in children and is the leading cause of mortality in developing countries.
In the last 20 years, despite several research, only a small decrease in morbidity and mortality has been achieved.
Corticosteroids have an immune-modulation effect, not completely elucidated. Most likely, this effect is due to down regulation of pro-inflammatory cytokines.
We postulate that adding corticosteroids to antibiotic treatment of CAP might change the immune response and thereby reduce morbidity, leading to a decrease in patients hospital length of stay.
- Conditions
- Community-acquired Pneumonia
- Being tested
- corticosteroid
- Keywords
- community-acquired pneumonia, children, respiratory infections
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroidDrug
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Experimental | Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day Receives: Drug: corticosteroid |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Measured: participants will be followed for the duration of hospital stay, usually 5 days
Secondary outcomes (2)
Length of fever
Measured: participants will be followed for the duration of hospital stay, usually 5 days
Length of oxygen use
Measured: participants will be followed for the duration of hospital stay, usually 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startNov 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Why it stopped: Unable to find patients matching inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Community-acquired 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romina N Chuminatti, MD, Principal investigator, Hospital General de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631916
- Sponsor's protocol ID
- HGNPE-66-2012
- Status last verified
- Feb 2016
- First submitted
- 26 Jun 2012
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meijvis 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 21636122Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P, Puccio G, Della Porta R, Giorgio C, Blasi F, Umberger R, Meduri GU. Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005 Feb 1;171(3):242-8. doi: 10.1164/rccm.200406-808OC. Epub 2004 Nov 19.
PubMed 15557131Weiss AK, Hall M, Lee GE, Kronman MP, Sheffler-Collins S, Shah SS. Adjunct corticosteroids in children hospitalized with community-acquired pneumonia. Pediatrics. 2011 Feb;127(2):e255-63. doi: 10.1542/peds.2010-0983. Epub 2011 Jan 10.
PubMed 21220397Snijders D, Daniels JM, de Graaff CS, van der Werf TS, Boersma WG. Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial. Am J Respir Crit Care Med. 2010 May 1;181(9):975-82. doi: 10.1164/rccm.200905-0808OC. Epub 2010 Feb 4.
PubMed 20133929
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01631916
- Acronym / sponsor ID
- HGNPE-66-2012
- Conditions
- Community-acquired Pneumonia
- Keywords
- community-acquired pneumonia, children, respiratory infections
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to find patients matching inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 29 Jun 2012 (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 the efficacy of addition of corticosteroid therapy to antibiotics in children hospitalized with community-acquired pneumonia.
The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia.
Detailed description
Community-acquired pneumonia (CAP) is a common problem in pediatric practice. The lower respiratory tract infections, particularly pneumonia, are a frequent cause of morbidity in children and is the leading cause of mortality in developing countries.
In the last 20 years, despite several research, only a small decrease in morbidity and mortality has been achieved.
Corticosteroids have an immune-modulation effect, not completely elucidated. Most likely, this effect is due to down regulation of pro-inflammatory cytokines.
We postulate that adding corticosteroids to antibiotic treatment of CAP might change the immune response and thereby reduce morbidity, leading to a decrease in patients hospital length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | Experimental | Drug: corticosteroidDexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children hospitalized for community-acquired pneumonia
- 2-18 years old
Key exclusion criteria (7 listed)
- Pulmonary chronic disease (including asthma)
- Immunodeficiency
- Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases)
- Wheezing in current disease
- Previous hospitalization (14 days prior to admission)
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 |
|---|---|---|
| corticosteroidDexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day | Drug | Corticosteroid |
Primary outcome
Length of stay
Time frame: participants will be followed for the duration of hospital stay, usually 5 days
2 secondary outcomes
Length of fever
Time frame: participants will be followed for the duration of hospital stay, usually 5 days
Length of oxygen use
Time frame: participants will be followed for the duration of hospital stay, usually 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Background: 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.
- Background: PubMed 15557131Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P, Puccio G, Della Porta R, Giorgio C, Blasi F, Umberger R, Meduri GU. Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005 Feb 1;171(3):242-8. doi: 10.1164/rccm.200406-808OC. Epub 2004 Nov 19.
- Background: PubMed 21220397Weiss AK, Hall M, Lee GE, Kronman MP, Sheffler-Collins S, Shah SS. Adjunct corticosteroids in children hospitalized with community-acquired pneumonia. Pediatrics. 2011 Feb;127(2):e255-63. doi: 10.1542/peds.2010-0983. Epub 2011 Jan 10.
- Background: PubMed 20133929Snijders D, Daniels JM, de Graaff CS, van der Werf TS, Boersma WG. Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial. Am J Respir Crit Care Med. 2010 May 1;181(9):975-82. doi: 10.1164/rccm.200905-0808OC. Epub 2010 Feb 4.
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Community-Acquired Pneumonia (CAP)
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.
Romina N Chuminatti, MD principal investigator
Hospital General de Niños Pedro de Elizalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corticosteroid in people with Community-acquired Pneumonia, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
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 7 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: withdrawn, as of the sponsor's last update on 29 Feb 2016. 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 Argentina. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 stay (time frame: participants will be followed for the duration of hospital stay, usually 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 NCT01631916, which also lists 4 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 29 Feb 2016.