Corticosteroids in Community-acquired Pneumonia

Not Applicable

Withdrawn

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: corticosteroid

• Registration Number: NCT01631916
• Lead Sponsor: Hospital General de Niños Pedro de Elizalde

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.

Study Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Study Start: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid	corticosteroid	Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Length of stay	participants will be followed for the duration of hospital stay, usually 5 days

Secondary Outcome Measures

Name	Time	Method
Length of fever	participants will be followed for the duration of hospital stay, usually 5 days
Length of oxygen use	participants will be followed for the duration of hospital stay, usually 5 days

Trial Locations

Locations (1)

Hospital General de NIños Pedro de Elizalde; 🇦🇷 Buenos Aires, CF, Argentina