Clinical Trial Corticoids For Empyema And Pleural Effusion In Children
Condition: Parapneumonic Pleural Effusion; Empyema
MeSH terms: Empyema; Pleural Effusion
Study type: Interventional
Phase: Phase 2

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 new
      treatment versus standard therapy.

      METHODS

        1. Study design: exploratory (pilot), randomized, double blinded, placebo controlled,
           parallel stratified design, multicentric.

        2. Participating Hospitals (n=56, 7 patients per center):

             -  Hospital Infanta Sofía (S. Sebastián de los Reyes, Madrid).

             -  Hospital Universitario de Getafe

             -  Hospital Universitario Ramón y Cajal, Madrid.

             -  Hospital Universitario Materno-Infantil Carlos Haya, Málaga.

             -  Hospital Infantil La Paz, Madrid.

             -  Hospital U. Gregorio Marañón

             -  Hospital U. Príncipe de Asturias

             -  Hospital Virgen de la Salud, Toledo

        3. Endpoints:

           3.1. Primary: time to resolution. 3.2. Secondary endpoints:

             1. Effectiveness: number of children with complications.

             2. Safety (expected number: none). i) Hyperglycemia ii) Signs of gastrointestinal
                bleeding iii) Need of transfusion iv) Oropharyngeal Candidiasis v) Allergic
                reaction vi) Other adverse reactions described in the Medication Guide.

        4. Treatment arms:

      3.1. Control (0)

        -  Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.

        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present.

        -  Ranitidine 5 mg/kg IV, q.d. for 2 days.

        -  Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days.

      3.2. Study treatment: (1)

        -  dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days.

        -  Cefotaxime 150 mg/kg, IV, q.d. until discharge criteria are present

        -  Ranitidine 5 mg/kg IV, q.d. for 2 days

        -  Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.

           4. INCLUSION CRITERIA

        -  Patients between 1 and 14 year old.

        -  Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and
           radiological consolidation.

        -  Evidence of pleural effusion.
    


Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days.
Cefotaxime 200 mg/kg, IV, q.d. until discharge criteria are present
Ranitidine 5 mg/kg IV, q.d. for 2 days
Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.; Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.
Cefotaxime 200 mg/kg, IV, q.d. until discharge criteria are present.
Ranitidine 5 mg/kg IV, q.d. for 2 days.
Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days.
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pleural effusion, empyema, corticoids, dexamethasone