Corticosteroids in Community-acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

Official title:

Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01631916
• Other study ID #: HGNPE-66-2012
• Status: Withdrawn
• Phase: N/A
• First received: June 26, 2012
• Last updated: February 26, 2016
• Start date: November 2015
• Est. completion date: March 2017

Study information

• Verified date: February 2016
• Source: Hospital General de Niños Pedro de Elizalde
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day

Locations

Country	Name	City	State
Argentina	Hospital General de NIños Pedro de Elizalde	Buenos Aires	CF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (4)

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. Epub 2004 Nov 19. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay		participants will be followed for the duration of hospital stay, usually 5 days	No
Secondary	Length of fever		participants will be followed for the duration of hospital stay, usually 5 days	No
Secondary	Length of oxygen use		participants will be followed for the duration of hospital stay, usually 5 days	No