Viral bronchiolitis MedDRA version: 14.0 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: SOLU-MODERIN 40 mg
Pharmaceutical Form: Powder for solution for injection/infusion
CAS Number: 2375-03-3
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Concentration unit: mg/
Sponsors
FUNDACIÓ SANT JOAN DE DÉU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will recruit paediatric patients under one year old who require hospitalization for moderate-severe bronchiolitis according to the HSJD BRONCHIOLITIS SCORE of Sant Joan de Deu Hospital (Annex 1). Are the trial subjects under 18? yes Number of subjects for this age range: 78 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Patients of either gender under one year old with mild bronchiolitis. b) Patients with bronchiolitis in which the principal symptom is apnoea. c) Patients who have received corticotherapy before admission to hospital. d) No consent from parents or tutors. e) Patients with previous acquired or innate immunodepression. f) Patients enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a) To determine whether a 7-day course of systemic glucocorticoids reduces the inflammatory activity in paediatric patients under one year-old diagnosed with moderate or severe bronchioloitis compared to a control group. b) To assess the morbidity in relation to clinical evolution (need for admission in the PICU-CCM, for mechanical ventilation, inotropes, nosocomial infection, rescue therapies for respiratory insufficiency; number of days in PICU and hospital stay; and death), in the treatment and control groups.;Secondary Objective: a) To study differences in inflammatory response and clinical evolution of patients diagnosed with moderate-severe bronchiolitis in relation to the causal pathogen. b) To study differences in the clinical evolution of patients diagnosed with moderate-severe bronchiolitis in relation to the causal pathogen between those receiving low doses of methylprednisolone/prednisolone and the control group. c) To study if the inflammatory response is different in patients requiring admission to the Intensive Care Unit than those who do not. d) To determine the side effects of the glucocorticoids.;Primary end point(s): The existence of differences in inflammatory response and clinical evolution of patients with moderate-severe bronchiolitis treated with methylprednisolone/prednisolone compared to those receiving placebo. Other key clinical variables studied include: Risk factors of severe bronchiolitis: prematurity, heart disease, previous respiratory condition, immune deficiency. Variables requiring clinical monitoring Heart rate (HR), Breathing rate (BR), blood pressure (BP), Daily HSJD BRONCHIOLITIS score (Annex 1). Analytical variables ? Inflammatory stimulants (IL-12, IFN-? and IL-2), inflammatory inhibitors (IL-4, IL-10), lymphocytic parameters (LT, LB, LT4 and LT8) and total Ig with Ig E. The values of interleukins and IFN-? will be determined by ELISA using commercially available reagents. White blood cell population | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary variables will be recorded: Demographic data Age, weight, gender. Day of admission to hospital. Protection factors Previous immunization with Palivizumab®. Severity factors on admission Paediatric risk score mortality (PRISM) III on admission (Annex 7), clinical severity of bronchiolitis according to the HSJD BRONCHIOLITIS SCORE (Annex 1) and radiographic pattern (interstitial, alveolar, mixed, ADRS). Etiological agent RSV-A, RSV-B, influenza A, Influenza B, influenza A/H1N1, adenovirus, metapneumovirus, rhinovirus, par influenza virus 1-4, enterovirus. The virus will be analyzed by PCR in a sample of nasopharyngeal aspirate. Respiratory viruses will be determined by the Luminex Xtag respiratory viral test.;Timepoint(s) of evaluation of this end point: Secondary variables will be studied during the study, mainly in the baseline visit. | — |
Countries
Spain
Contacts
Public ContactFUNDACIÓ SANT JOAN DE DÉU
FUNDACIÓ SANT JOAN DE DÉU
Outcome results
None listed