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Withdrawn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
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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 |
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 (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 |

Arm | Intervention/treatment |
---|---|
Experimental: Corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
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Drug: corticosteroid
Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day |
No Intervention: Control
No intervention
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- Length of stay [ Time Frame: participants will be followed for the duration of hospital stay, usually 5 days ]
- Length of fever [ Time Frame: 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 ]

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Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Argentina | |
Hospital General de NIños Pedro de Elizalde | |
Buenos Aires, CF, Argentina, C1270AAN |
Principal Investigator: | Romina N Chuminatti, MD | Hospital General de Niños Pedro de Elizalde |
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 |
community-acquired pneumonia children respiratory infections |
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |