Recurrent Respiratory Tract Infection MedDRA version: 20.1 Level: LLT Classification code 10039249 Term: RTI System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Broncho- vaxom
Product Name: Broncho-vaxom
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lisato battericoliofilizzato di H influenzae, S pneumoniae, K pneumoniae ssp pneumoniae e
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of written informed consent from parents/legal guardian prior to any study procedures Preschool children of both gender, aged 1 to 6 years Six or more acute respiratory tract illnesses in the previous year or 4 episodes of infectious bronchospasm (according to medical records from outpatient clinics) Are the trial subjects under 18? yes Number of subjects for this age range: 1 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: Anatomic alterations of the respiratory tract Other chronic respiratory diseases (i.e., persistent wheezing requiring stable therapy with inhalatory steroids, tuberculosis or cystic fibrosis) Severe primary immunodeficiency or HIV infection Any autoimmune disease Liver or kidney failure Malnutrition Any known neoplasia or malignancy Treatment with the following medications: Antibiotics, systemic, inhaled or oral steroids (e.g., oral prednisolone) within 4 weeks before Visit 1, oral vaccination with live vaccine within 4 weeks before Visit 1, long-term azithromycin therapy within 3 months before Visit 1, previous and/or concomitant immunosuppressants, Immunostimulants, gamma globulins, or anticonvulsive drugs therapy within 6 months before Visit 1 Any major surgery within the last 3 months prior to study enrolment Known allergy or previous intolerance to study medication or to any components/excipients of the study medication; Severe immunodeficiency. Any other clinical conditions, in the opinion of the investigator, that would not allow safe completion of the clinical study Parents/legal guardians not willing or unable to give written informed consent Participant's families may not be expected to relocate out of study area within 1 year of the initiation of the study Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or receiving other investigational agent(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of OM-85 administered at the standard regimen (10 days for 3 consecutive months) in reducing the number of acute respiratory tract infections during the infective season in preschool children with previous recurrent respiratpry tract infections.;Secondary Objective: assess the efficacy of OM-85 administered for 3 or 6 months in reducing the number of acute RTIs lasting (a) at least 2 days or (b) at least 3 days assess the efficacy of OM-85 administered for 3 or 6 months in lowering the duration of acute RTIs; assess the efficacy of OM-85 administered for 3 or 6 months in increasing the number of days free from any symptoms of RTIs; assess the efficacy of OM-85 administered for 3 or 6 months in reducing the number of upper and lower RTIs; assess the efficacy of OM-85 administered for 3 or 6 months in reducing the duration of upper and lower RTIs; assess the efficacy of OM-85 administered for 3 or 6 months in reducing the number of bacterial pharyngotonsillitis and AOM; assess the efficacy of OM-85 administered for 3 or 6 months in reducing the duration of bacterial pharyngotonsillitis and AOM assess the efficacy of OM-85 administered for 3 or 6 months in reducing antibiotic use; assess the efficacy of OM-85 administered for 3 or 6 months in reduci;Primary end point(s): Mean cumulative number of acute respiratory tract infections over 6 months ;Timepoint(s) of evaluation of this end point: 6 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety, including AEs, SAEs, vital signs, physical examination and laboratory parameters;Timepoint(s) of evaluation of this end point: 6 MONTHS | — |
Countries
Italy
Contacts
Public ContactU.O.S.D. PEDIATRIA AD ALTA INTENSIT
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Outcome results
None listed