Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-11-30
2017-03-31
Brief Summary
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The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
Control
No intervention
No interventions assigned to this group
Interventions
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corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
Eligibility Criteria
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Inclusion Criteria
* 2-18 years old
Exclusion Criteria
* 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
2 Years
18 Years
ALL
No
Sponsors
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Hospital General de Niños Pedro de Elizalde
OTHER
Responsible Party
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Principal Investigators
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Romina N Chuminatti, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Niños Pedro de Elizalde
Locations
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Hospital General de NIños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina
Countries
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References
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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.
Confalonieri 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.
Weiss 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.
Snijders 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.
Other Identifiers
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HGNPE-66-2012
Identifier Type: -
Identifier Source: org_study_id
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