Clinical Trial Corticoids ForO Empyema And Pleural Eeffusion In Children
Information source: Hospital Infanta Sofia
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parapneumonic Pleural Effussion; Empyema
Intervention: Dexamethasone (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hospital Infanta Sofia Overall contact:
Alfredo Tagarro, Ph D, Phone: 34 606194888, Email: alfredo.tagarro@salud.madrid.org
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
Dexametasone 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 Dexametasone
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 Dexametasone 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 Dexametasone 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) Oropharingeal 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)
- Dexametasone 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.
Clinical Details
Official title: MULTICENTRIC, PHASE II, CLINICAL TRIAL CORTICOIDS FOR EMPYEMA AND PLEURAL EFFUSION IN CHILDREN
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: time to resolution
Secondary outcome: number of children with complications.Number of children with complications attributable to corticoids
Eligibility
Minimum age: 1 Month.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
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.
Exclusion Criteria:
- Allergy to any of the drugs included in the study.
- Immunodeficiency.
Locations and Contacts
Alfredo Tagarro, Ph D, Phone: 34 606194888, Email: alfredo.tagarro@salud.madrid.org
Hospital Infantil La Paz, Madrid 28037, Spain; Recruiting
Fernando Baquero, MD
Fernando Baquero, MD, Principal Investigator
Cristina Ots, MD, Sub-Investigator
Hospital Ramón y Cajal, Madrid, Spain; Recruiting
Enrique Otheo, MD
Enrique Otheo, MD, Principal Investigator
Hospital Universitario Gregorio Marañón, Madrid, Spain; Recruiting
Marisa Navarro, PhD
Maria Luisa Navarro, PhD, Principal Investigator
Hospital Carlos Haya, Malaga, Andalucia, Spain; Recruiting
David Moreno, PhD
David Moreno, PhD, Principal Investigator
Complejo Hospitalario Toledo, Toledo, Castilla La Mancha, Spain; Recruiting
Rosa Velasco, MD
Rosa Velasco, MD, Principal Investigator
Hospital Principe de Asturias, Alcalá de Henares, Madrid, Spain; Recruiting
María Penin, MD
Maria Penin, Sub-Investigator
Hospital Universitario de Getafe, Getafe, Madrid, Spain; Recruiting
Marta Ruiz, MD
Marta Ruiz, Principal Investigator
Hospital Infanta Sofia, San Sebastián de los Reyes, Madrid 28014, Spain; Recruiting
ALFREDO TAGARRO, PH D, Phone: 34 606194888
ALFREDO TAGARRO, PH D, Principal Investigator
Additional Information
Starting date: December 2010
Last updated: December 20, 2010
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