Corticosteroids in Community-acquired Pneumonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hospital General de Niños Pedro de Elizalde.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014