Clinical Trial: Clinical Trial Corticoids For Empyema And Pleural Effusion In Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: MULTICENTRIC, PHASE II, CLINICAL TRIAL CORTICOIDS FOR EMPYEMA AND PLEURAL EFFUSION IN CHILDREN

Brief Summary:

STUDY JUSTIFICATION

  1. Scientific evidence of the usefulness of corticosteroid use for infectious diseases: Corticosteroids along with antibiotic use improve survival in some infectious processes provide long term benefits and improve symptoms in many others.
  2. Clinical Observation: the investigators observed that patients with parapneumonic pleural effusion and associated bronchospasm who were treated with corticosteroids for their bronchospasm, evolved to healing before patients who were not treated with corticosteroids (average admission days 10 vs. 17).
  3. Rationale: the anti-inflammatory effect has been the rationale for the use of dexamethasone as an inhibitor of the inflammatory response observed after the first dose of parenteral antibiotic in bacterial meningitis. A similar effect is likely to occur in pneumonia with pleural effusion. It can be therefore hypothesized that Dexamethasone could inhibit an excessive inflammatory response by mesothelial and inflammatory cells during the early phases of parapneumonic empyema, reducing its severity and hence its complications.

OBJECTIVES

  1. Principal: to investigate if dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic therapy reduces time to resolution of parapneumonic pleural effusion.
  2. Secondary:

2.1. Evaluate the effect of dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic therapy on the development of complications during pleural effusion episode.

2.2. Evaluate the incidence of severe and non severe adverse events associated with the

Detailed Summary:
Sponsor: Hospital Infanta Sofia

Current Primary Outcome: time to resolution [ Time Frame: 1 month after admission ]

days from diagnosis until criteria for cure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of children with complications. [ Time Frame: 3 months after diagnosis ]
    number of children with complications.
  • Number of children with complications attributable to corticoids [ Time Frame: 3 months ]
    Hyperglycemia Signs of gastrointestinal bleeding Need of transfusion Oropharyngeal Candidiasis Allergic reaction


Original Secondary Outcome:

  • number of children with complications. [ Time Frame: 3 months after diagnosis ]
    number of children with complications.
  • Number of children with complications attributable to corticoids [ Time Frame: 3 months ]
    Hyperglycemia Signs of gastrointestinal bleeding Need of transfusion Oropharingeal Candidiasis Allergic reaction


Information By: Hospital Infanta Sofia

Dates:
Date Received: December 15, 2010
Date Started: December 2010
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015