Clinical Trial Corticoids For Empyema And Pleural Effusion In Children
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Hospital Infanta Sofia
Collaborators:
Pediatrics Spanish Association (Madrid and Castilla-La Mancha Pediatric Association) Spanish Ministry of Health.