CORTEEC: Clinical Trial Corticoids For Empyema And Pleural Effusion In Children

• Sponsor: Hospital Infanta Sofia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01261546
• Collaborator: Pediatrics Spanish Association (Madrid and Castilla-La Mancha Pediatric Association) (Other), Spanish Ministry of Health. (Other)
• Enrollment: 60
• Locations: 8
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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

1. 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.

3. 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.

1. 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 or Disease	Intervention/Treatment	Phase
Parapneumonic Pleural Effusion; Empyema	Drug: Dexamethasone; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: MULTICENTRIC, PHASE II, CLINICAL TRIAL CORTICOIDS FOR EMPYEMA AND PLEURAL EFFUSION IN CHILDREN
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. time to resolution [1 month after admission]

   days from diagnosis until criteria for cure

Secondary Outcome Measures

1. number of children with complications. [3 months after diagnosis]

   number of children with complications.

2. Number of children with complications attributable to corticoids [3 months]

   Hyperglycemia Signs of gastrointestinal bleeding Need of transfusion Oropharyngeal Candidiasis Allergic reaction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Carlos Haya	Malaga	Andalucia	Spain
2	Complejo Hospitalario Toledo	Toledo	Castilla La Mancha	Spain
3	Hospital Principe de Asturias	Alcalá de Henares	Madrid	Spain
4	Hospital Universitario de Getafe	Getafe	Madrid	Spain
5	Hospital Infanta Sofia	San Sebastián de los Reyes	Madrid	Spain	28014
6	Hospital Infantil La Paz	Madrid		Spain	28037
7	Hospital Ramón y Cajal	Madrid		Spain
8	Hospital Universitario Gregorio Marañón	Madrid		Spain

Sponsors and Collaborators

• Hospital Infanta Sofia
• Pediatrics Spanish Association (Madrid and Castilla-La Mancha Pediatric Association)
• Spanish Ministry of Health.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Infanta Sofia
• ClinicalTrials.gov Identifier: NCT01261546
• Other Study ID Numbers: Hospital Infanta Sofia; 2009-012963-33
• First Posted: Dec 16, 2010
• Last Update Posted: Jun 1, 2015
• Last Verified: May 1, 2015

• Keywords provided by Hospital Infanta Sofia: pleural effusion, empyema, corticoids, dexamethasone
• Additional relevant MeSH terms: Empyema; Pleural Effusion; Dexamethasone

Study Results

No Results Posted as of Jun 1, 2015