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Clinical Trial Corticoids For Empyema And Pleural Effusion In Children

Information source: Hospital Infanta Sofia
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parapneumonic Pleural Effusion; 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 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.

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; Completed

Hospital Ramón y Cajal, Madrid, Spain; Completed

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; Completed

Additional Information

Starting date: December 2010
Last updated: April 7, 2014

Page last updated: November 27, 2014

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