NCT01631916

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
3.3 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

June 26, 2012

Last Update Submit

February 26, 2016

Conditions

Community-acquired Pneumonia

Keywords

community-acquired pneumoniachildrenrespiratory infections

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    participants will be followed for the duration of hospital stay, usually 5 days

Secondary Outcomes (2)

  • 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

Study Arms (2)

Corticosteroid

EXPERIMENTAL

Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day

Drug: corticosteroid

Control

NO INTERVENTION

No intervention

Interventions

corticosteroidDRUG

Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day

Corticosteroid

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children hospitalized for community-acquired pneumonia
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de NIños Pedro de Elizalde

Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina

Location

Related Publications (4)

  • Meijvis SC, Hardeman H, Remmelts HH, Heijligenberg R, Rijkers GT, van Velzen-Blad H, Voorn GP, van de Garde EM, Endeman H, Grutters JC, Bos WJ, Biesma DH. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.

    PMID: 21636122BACKGROUND

  • Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P, Puccio G, Della Porta R, Giorgio C, Blasi F, Umberger R, Meduri GU. Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005 Feb 1;171(3):242-8. doi: 10.1164/rccm.200406-808OC. Epub 2004 Nov 19.

    PMID: 15557131BACKGROUND

  • Weiss AK, Hall M, Lee GE, Kronman MP, Sheffler-Collins S, Shah SS. Adjunct corticosteroids in children hospitalized with community-acquired pneumonia. Pediatrics. 2011 Feb;127(2):e255-63. doi: 10.1542/peds.2010-0983. Epub 2011 Jan 10.

    PMID: 21220397BACKGROUND

  • Snijders D, Daniels JM, de Graaff CS, van der Werf TS, Boersma WG. Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial. Am J Respir Crit Care Med. 2010 May 1;181(9):975-82. doi: 10.1164/rccm.200905-0808OC. Epub 2010 Feb 4.

    PMID: 20133929BACKGROUND

MeSH Terms

Conditions

Community-Acquired PneumoniaRespiratory Tract Infections

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Romina N Chuminatti, MD

    Hospital General de Niños Pedro de Elizalde

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 29, 2012

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

February 29, 2016

Record last verified: 2016-02

Locations

AR(1)