Clinical Trial Corticoids For Empyema And Pleural Effusion In Children (CORTEEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospital Infanta Sofia
Sponsor:
Collaborators:
Pediatrics Spanish Association (Madrid and Castilla-La Mancha Pediatric Association)
Spanish Ministry of Health.
Information provided by (Responsible Party):
Hospital Infanta Sofia
ClinicalTrials.gov Identifier:
NCT01261546
First received: December 15, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention Phase
Parapneumonic Pleural Effusion
Empyema
Drug: Dexamethasone
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hospital Infanta Sofia:

Primary Outcome Measures:
  • time to resolution [ Time Frame: 1 month after admission ] [ Designated as safety issue: No ]
    days from diagnosis until criteria for cure


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 56
Study Start Date: December 2010
Estimated Study Completion Date: July 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone
  • 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.
Drug: Dexamethasone
  • 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.
Placebo Comparator: Placebo

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.
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   1 Month to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261546

Contacts
Contact: Alfredo Tagarro, Ph D 34 606194888 alfredo.tagarro@salud.madrid.org

Locations
Spain
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
Madrid, Spain
Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain
Contact: Marisa Navarro, PhD         
Principal Investigator: Maria Luisa Navarro, PhD         
Sponsors and Collaborators
Hospital Infanta Sofia
Pediatrics Spanish Association (Madrid and Castilla-La Mancha Pediatric Association)
Spanish Ministry of Health.
  More Information

No publications provided

Responsible Party: Hospital Infanta Sofia
ClinicalTrials.gov Identifier: NCT01261546     History of Changes
Other Study ID Numbers: Hospital Infanta Sofia, 2009-012963-33
Study First Received: December 15, 2010
Last Updated: April 7, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Infanta Sofia:
pleural effusion, empyema, corticoids, dexamethasone

Additional relevant MeSH terms:
Empyema
Pleural Effusion
Infection
Inflammation
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Suppuration
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
BB 1101
Clavulanic Acid
Clavulanic Acids
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 23, 2014