Clinical Trial Corticoids For Empyema And Pleural Effusion In Children

NCT01261546 | Completed Phase 2 DMC

• 2 other identifiers: Hospital Infanta Sofia2009-012963-33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief Summary

STUDY JUSTIFICATION

• 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
• 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:
• 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.

Conditions

Parapneumonic Pleural Effusion; Empyema

Keywords

pleural effusion, empyema, corticoids, dexamethasone

Outcome Measures

Primary Outcomes (1)

• time to resolution

  days from diagnosis until criteria for cure

  1 month after admission

Secondary Outcomes (2)

• number of children with complications.

  3 months after diagnosis

• Number of children with complications attributable to corticoids

  3 months

Study Arms (2)

Dexamethasone

EXPERIMENTAL

* 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

Placebo

PLACEBO COMPARATOR

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

Interventions

Dexamethasone DRUG

* 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.

Dexamethasone

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Allergy to any of the drugs included in the study.
• Immunodeficiency.

Sponsors & Collaborators

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

Study Sites (8)

Hospital Carlos Haya

Málaga, Andalusia, Spain

Location

Complejo Hospitalario Toledo

Toledo, Castille-La Mancha, Spain

Location

Hospital Principe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Location

Hospital Infantil La Paz

Madrid, Madrid, 28037, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, Madrid, Spain

Location

Hospital Infanta Sofia

San Sebastián de los Reyes, Madrid, 28014, Spain

Location

Related Publications (1)

• Tagarro A, Otheo E, Baquero-Artigao F, Navarro ML, Velasco R, Ruiz M, Penin M, Moreno D, Rojo P, Madero R; CORTEEC Study Group. Dexamethasone for Parapneumonic Pleural Effusion: A Randomized, Double-Blind, Clinical Trial. J Pediatr. 2017 Jun;185:117-123.e6. doi: 10.1016/j.jpeds.2017.02.043. Epub 2017 Mar 28.

  PMID: 28363363 DERIVED

MeSH Terms

Conditions

Empyema; Pleural Effusion

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

ES (8)