Clinical Trial Corticoids For Empyema And Pleural Effusion In Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children

NCT01757899

Acute Lung Injury Acute Respiratory Distress Syndrome

WITHDRAWN PHASE2

Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

NCT06429982

Rhabdomyolysis

RECRUITING PHASE1

Use of Corticosteroids in Children With Cellulitis

NCT02087527

Cellulitis

TERMINATED NA

Dornase Alfa and Urokinase for Kids With Pleural Empyema

NCT00502632

Pleural Empyema

UNKNOWN PHASE2/PHASE3

Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

NCT00199576

Post-Extubation Laryngeal Edema

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parapneumonic Pleural Effusion Empyema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.