Clinical Trial Corticoids For Empyema And Pleural Effusion In Children (CORTEEC)
- 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.
- 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).
- 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.
- Principal: to investigate if dexamethasone 0,25mg/kg q.i.d. added to standard antibiotic therapy reduces time to resolution of parapneumonic pleural effusion.
2.1. 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.
- Study design: exploratory (pilot), randomized, double blinded, placebo controlled, parallel stratified design, multicentric.
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
3.1. Primary: time to resolution. 3.2. Secondary endpoints:
- Effectiveness: number of children with complications.
- 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.
- 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.
Parapneumonic Pleural Effusion
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||MULTICENTRIC, PHASE II, CLINICAL TRIAL CORTICOIDS FOR EMPYEMA AND PLEURAL EFFUSION IN CHILDREN|
- time to resolution [ Time Frame: 1 month after admission ] [ Designated as safety issue: No ]days from diagnosis until criteria for cure
- number of children with complications. [ Time Frame: 3 months after diagnosis ] [ Designated as safety issue: No ]number of children with complications.
- Number of children with complications attributable to corticoids [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Hyperglycemia Signs of gastrointestinal bleeding Need of transfusion Oropharyngeal Candidiasis Allergic reaction
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.
Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.
|Contact: Alfredo Tagarro, Ph D||34 firstname.lastname@example.org|
|Hospital Carlos Haya||Recruiting|
|Malaga, Andalucia, Spain|
|Contact: David Moreno, PhD|
|Principal Investigator: David Moreno, PhD|
|Complejo Hospitalario Toledo||Recruiting|
|Toledo, Castilla La Mancha, Spain|
|Contact: Rosa Velasco, MD|
|Principal Investigator: Rosa Velasco, MD|
|Hospital Principe de Asturias||Recruiting|
|Alcalá de Henares, Madrid, Spain|
|Contact: María Penin, MD|
|Sub-Investigator: Maria Penin|
|Hospital Universitario de Getafe||Recruiting|
|Getafe, Madrid, Spain|
|Contact: Marta Ruiz, MD|
|Principal Investigator: Marta Ruiz|
|Hospital Infanta Sofia||Completed|
|San Sebastián de los Reyes, Madrid, Spain, 28014|
|Hospital Infantil La Paz||Completed|
|Madrid, Spain, 28037|
|Hospital Ramón y Cajal||Completed|
|Hospital Universitario Gregorio Marañón||Recruiting|
|Contact: Marisa Navarro, PhD|
|Principal Investigator: Maria Luisa Navarro, PhD|