search
Back to results

Corticosteroids in Community-acquired Pneumonia

Primary Purpose

Community-acquired Pneumonia

Status
Withdrawn
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
corticosteroid
Sponsored by
Hospital General de Niños Pedro de Elizalde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring community-acquired pneumonia, children, respiratory infections

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General de NIños Pedro de Elizalde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Corticosteroid

Control

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

Length of stay

Secondary Outcome Measures

Length of fever
Length of oxygen use

Full Information

First Posted
June 26, 2012
Last Updated
February 26, 2016
Sponsor
Hospital General de Niños Pedro de Elizalde
search

1. Study Identification

Unique Protocol Identification Number
NCT01631916
Brief Title
Corticosteroids in Community-acquired Pneumonia
Official Title
Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to find patients matching inclusion criteria
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General de Niños Pedro de Elizalde

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
community-acquired pneumonia, children, respiratory infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid
Arm Type
Experimental
Arm Description
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
corticosteroid
Intervention Description
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
Primary Outcome Measure Information:
Title
Length of stay
Time Frame
participants will be followed for the duration of hospital stay, usually 5 days
Secondary Outcome Measure Information:
Title
Length of fever
Time Frame
participants will be followed for the duration of hospital stay, usually 5 days
Title
Length of oxygen use
Time Frame
participants will be followed for the duration of hospital stay, usually 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romina N Chuminatti, MD
Organizational Affiliation
Hospital General de Niños Pedro de Elizalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de NIños Pedro de Elizalde
City
Buenos Aires
State/Province
CF
ZIP/Postal Code
C1270AAN
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
21636122
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.
Results Reference
background
PubMed Identifier
15557131
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.
Results Reference
background
PubMed Identifier
21220397
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.
Results Reference
background
PubMed Identifier
20133929
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.
Results Reference
background

Learn more about this trial

Corticosteroids in Community-acquired Pneumonia

We'll reach out to this number within 24 hrs