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Corticosteroids in Community-acquired Pneumonia

This study is currently recruiting participants.
Verified July 2012 by Hospital General de Niños Pedro de Elizalde
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01631916
First received: June 26, 2012
Last updated: May 14, 2013
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Community-acquired Pneumonia
 Drug: corticosteroid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia Steroids
U.S. FDA Resources

Further study details as provided by Hospital General de Niños Pedro de Elizalde:

Primary Outcome Measures:
  • Length of stay [ Time Frame: participants will be followed for the duration of hospital stay, usually 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of fever [ Time Frame: participants will be followed for the duration of hospital stay, usually 5 days ] [ Designated as safety issue: No ]
  • Length of oxygen use [ Time Frame: participants will be followed for the duration of hospital stay, usually 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
 Drug: corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
No Intervention: Control
No intervention

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

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631916

Contacts
Contact: Romina N Chuminatti, MD 54 11 43632100 ext 1014 rhomi981@yahoo.com.ar
Contact: Delfina Inda, MD 54 11 43632100 ext 1014 delfiinda@hotmail.com

Locations
Argentina
Hospital General de NIños Pedro de Elizalde Recruiting
Buenos Aires, CF, Argentina, C1270AAN
Contact: Fernando C Ferrero, MD     54 11 43070140     fferrero@intramed.net    
Principal Investigator: Romina N Chuminatti, MD            
Sub-Investigator: Delfina Inda, MD            
Sub-Investigator: Mariel Ormazabal, MD            
Sub-Investigator: Maria C Danesi, MD            
Sub-Investigator: Maria L Moreyra, MD            
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
Principal Investigator: Romina N Chuminatti, MD Hospital General de Niños Pedro de Elizalde
  More Information

Publications:

Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01631916     History of Changes
Other Study ID Numbers: HGNPE-66-2012
Study First Received: June 26, 2012
Last Updated: May 14, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital General de Niños Pedro de Elizalde:
community-acquired pneumonia
children
respiratory infections

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on June 18, 2013