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Corticosteroids in Community-acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT01631916
Recruitment Status : Withdrawn (Unable to find patients matching inclusion criteria)
First Posted : June 29, 2012
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde

Study Description
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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.


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: corticosteroid Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia
Study Start Date : November 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Steroids

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Length of stay [ Time Frame: participants will be followed for the duration of hospital stay, usually 5 days ]

Secondary Outcome Measures :
  1. Length of fever [ Time Frame: participants will be followed for the duration of hospital stay, usually 5 days ]
  2. Length of oxygen use [ Time Frame: participants will be followed for the duration of hospital stay, usually 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631916


Locations
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Argentina
Hospital General de NIños Pedro de Elizalde
Buenos Aires, CF, Argentina, C1270AAN
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
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Principal Investigator: Romina N Chuminatti, MD Hospital General de Niños Pedro de Elizalde
More Information
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Publications:

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Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01631916    
Other Study ID Numbers: HGNPE-66-2012
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016
Keywords provided by Hospital General de Niños Pedro de Elizalde:
community-acquired pneumonia
children
respiratory infections
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections