Corticosteroids in Community-acquired Pneumonia

NCT ID: NCT01631916

Last Updated: 2016-02-29

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Corticosteroid

Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day

Group Type EXPERIMENTAL

corticosteroid

Intervention Type DRUG

Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day

Control

No intervention

Group Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General de Niños Pedro de Elizalde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Argentina

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.

Reference Type BACKGROUND
PMID: 21636122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15557131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21220397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20133929 (View on PubMed)

Other Identifiers

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HGNPE-66-2012

Identifier Type: -

Identifier Source: org_study_id

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