Prevention With Ismigen of RTIs in Kids
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-12
SponsorLallemand Pharma AG
About this trial
Although the efficacy of PMBL® sublingual tablets is evident to most prescribers, the clinical studies available to demonstrate the efficacy of this bacterial lysate in preventing recurrent respiratory tract infections have undeniable methodological biases. To demonstrate the efficacy of PMBL® in the pediatric population without questionable bias, a randomized double-blind Placebo-controlled study will be conducted: one arm of children presenting with a risk of recurrent respiratory tract infections will be treated with PMBL® for a 3-month period, 10 days per months during the fall-winter whereas subjects of the Placebo arm will receive sublingual tablet indistinguishable from PMBL® but without active ingredients. Both groups of subjects will be followed for four additional months. To improve the accuracy of data and the tracking of respiratory tract infections (RTI), a diary will be provided to each subject, allowing them to report the event as soon as it occurs. If necessary, a visit may be planned to enable the investigator to assess the event accurately.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children of both genders aged from 3 to 12 years.
Written informed consent obtained from the parents/legally authorized representatives
Written assent obtained from the subject from 7 years
Subject presenting with a susceptibility to respiratory tract infections according to the investigator
Disqualifiers
Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment.
Body temperature ≥ 37.5°C at the randomization visit.
Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.
Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis.
Trial design
Design model
Parallel
Treatments tested in this trial
Bacterial Lysates
Drug3-month period, 10 days per months during the fall-winter
Placebo
Drug3-month period, 10 days per months during the fall-winter
Treatment groups
224 Participants
are divided into 2 treatment groupsGroup A: PMBL® sublingual tabletActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The total number of RTIs experienced by each subject throughout the 7-month study period (3-month treatment + 4-month follow-up).
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.
Time frame
Throughout the 7-month study period (3-month treatment + 4-month follow-up).Secondary outcomes
1
Mean duration in days per RTI during the overall study period.
Estimated treatment effect from MMRM with 95% CI.
Time frame
Throughout the 7-month study period (3-month treatment + 4-month follow-up).2
Number of days with respiratory tract infections during the overall study period
Negative binomial or Poisson regression with 95% CI.
Time frame
Throughout the 7-month study period (3-month treatment + 4-month follow-up).3
Number of days of antibiotics use during the overall study period
Estimated incidence rate ratio (IRR) using negative binomial regression (or Poisson if appropriate) with 95% CI.
Time frame
Throughout the 7-month study period (3-month treatment + 4-month follow-up).4
Total number of workdays lost by parents due to their child's respiratory infections during the overall study period.
Total number of workdays lost by children's parents due to the child's respiratory infections during the overall study period (cumulative days) For each endpoint: mean (SD), median (IQR), and cumulative counts by treatment arm; primary between-group effect presented as an incidence rate ratio (IRR) with 95% CI (PMBL® vs placebo). Absolute mean difference and 95% CI will also be provided for interpretability
Time frame
Throughout the study (3 month-treatment period and 4 month-follow-up)Sponsors and contacts
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Source ClinicalTrials.gov