Corticosteroids in Community-acquired Pneumonia

February 26, 2016 updated by: Hospital General de Niños Pedro de Elizalde

Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • CF
      • Buenos Aires, CF, Argentina, C1270AAN
        • Hospital General de Niños Pedro de Elizalde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
No intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of stay
Time Frame: participants will be followed for the duration of hospital stay, usually 5 days
participants will be followed for the duration of hospital stay, usually 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of fever
Time Frame: participants will be followed for the duration of hospital stay, usually 5 days
participants will be followed for the duration of hospital stay, usually 5 days
Length of oxygen use
Time Frame: participants will be followed for the duration of hospital stay, usually 5 days
participants will be followed for the duration of hospital stay, usually 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Niños Pedro de Elizalde

Investigators

  • Principal Investigator: Romina N Chuminatti, MD, Hospital General de Niños Pedro de Elizalde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (ESTIMATE)

June 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNPE-66-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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