A randomized double-blind placebo-controlled study to demonstrate the efficacy of PMBL® sublingual tablets in reducing the incidence of respiratory tract infections in children aged 3-12 years (PIRTIK).
Phase 4 – monitoring after market approval
Conditions:
Respiratory Tract Infections
Sponsor: Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz
trial.available_in:
БГ
Overview
Trial status: Authorised
- % of pts free of RTI during the overall study period - Mean duration in days per RTI during the overall study period (OST) – No. of days with RTI during the OST – No. of days of antibiotics use during the OST - Total no. of workdays lost by parents due to their child’s RTI during the OST – No. of physician consultations due to RTI or related complications – No. of antibiotic treatments (courses) for a respiratory event during the OST – No. of pts with (serious) AE and (serious) ADR
Rate of Respiratory Tract Infections (RTIs): the number of RTIs experienced by a subject throughout the study (3 month-treatment period and 4 month-follow-up) will be assessed.
Description
- % of pts free of RTI during the overall study period - Mean duration in days per RTI during the overall study period (OST) – No. of days with RTI during the OST – No. of days of antibiotics use during the OST - Total no. of workdays lost by parents due to their child’s RTI during the OST – No. of physician consultations due to RTI or related complications – No. of antibiotic treatments (courses) for a respiratory event during the OST – No. of pts with (serious) AE and (serious) ADR
Who can participate
Age group: 0-17 years
Gender: Female, Male
Target enrollment: 224 participants
БГ