Clinical trial NCT01631916: Corticosteroids in Community-acquired Pneumonia
Official title: Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: community-acquired pneumonia
children
respiratory infections
Lead sponsor: Hospital General de Niños Pedro de Elizalde
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Children hospitalized for community-acquired pneumonia
* 2-18 years old

Exclusion Criteria:

* 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

Primary outcomes:
measure: Length of stay
timeFrame: participants will be followed for the duration of hospital stay, usually 5 days
Secondary outcomes:
measure: Length of fever
timeFrame: participants will be followed for the duration of hospital stay, usually 5 days
measure: Length of oxygen use
timeFrame: participants will be followed for the duration of hospital stay, usually 5 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de NIños Pedro de Elizalde
state: CF
Study officials:
affiliation: Hospital General de Niños Pedro de Elizalde
name: Romina N Chuminatti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.