LYOPHILIZED BACTERIAL LYSATES OF: HAEMOPHILUS INFLUENZAE; STREPTOCOCCUS (DIPLOCOCCUS) PNEUMONIAE; KLEBSIELLA PNEUMONIAE AND OZAENAE; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PYOGENES AND VIRIDANS; MORAXELLA (BRANHAMELLA / NEISSERIA) CATARRHALIS for Lower respiratory tract infections | Wheezing in moderate-late preterm infants

Inclusion criteria

• {"criterion_text":"- Gestational age at delivery between 30+0 and 35+6 weeks\n- Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks\n- Written informed consent by both parents or formal caregivers"}

Exclusion criteria

• {"criterion_text":"- Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (un-expected in this group); hemodynamic significant cardiac disease; immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor neurological outcome; syn-drome or serious congenital disorder.\n- Dysmaturity and/or weight < 2.5 kg at age of randomization\n- Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding\n- Parents unable to speak and read Dutch/English language\n- Known allergic hypersensitivity to the active ingredients/substance or to any of the ex-cipients."}

Primary endpoints

• {"endpoint_text":"- Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life.","definition_or_measurement_approach":"Count of physician-diagnosed lower respiratory tract infections and wheezing episodes occurring during the participant's first year of life."}
• {"endpoint_text":"- Protea-2: The time to the first lower respiratory episode after 12 months of age.","definition_or_measurement_approach":"Time-to-event measure: time from defined baseline to first lower respiratory episode occurring after 12 months of age."}

Secondary endpoints

• {"endpoint_text":"- time to first lower RTI or wheezing episode in the first year of life","definition_or_measurement_approach":"Time-to-event: time from baseline to first lower RTI or wheezing episode within the first year of life."}
• {"endpoint_text":"- total number of RTI in the first and second year of life","definition_or_measurement_approach":"Count of respiratory tract infections occurring during the first and second years of life."}
• {"endpoint_text":"- total number of wheezing episodes in the first and second year of life","definition_or_measurement_approach":"Count of wheezing episodes occurring during the first and second years of life."}
• {"endpoint_text":"- distribution of viruses during lower RTI/wheezing","definition_or_measurement_approach":"Virological assessment of causative viruses during episodes of lower RTI/wheezing (distribution by virus type)."}
• {"endpoint_text":"- medication use (bronchodilators, corticosteroids, antibiotics)","definition_or_measurement_approach":"Recording and summary of medication use during follow-up (bronchodilators, corticosteroids, antibiotics)."}
• {"endpoint_text":"- lung function as measured by expiratory variability index","definition_or_measurement_approach":"Lung function assessed using expiratory variability index measurements."}
• {"endpoint_text":"- quality of life","definition_or_measurement_approach":"Assessment of quality of life using study-specified QoL instruments (not further specified in extracted data)."}
• {"endpoint_text":"- (serious) adverse events (respiratory episodes are not regarded as an (S)AE since they comprise primary and secondary outcomes)","definition_or_measurement_approach":"Recording and classification of adverse events and serious adverse events; respiratory episodes are excluded from AE classification as they are outcomes."}
• {"endpoint_text":"- serum specific IgE (allergen sensitization) at 12 months","definition_or_measurement_approach":"Measurement of serum-specific IgE at 12 months to assess allergen sensitization."}
• {"endpoint_text":"- infant vaccination titers at 12 months","definition_or_measurement_approach":"Measurement of infant vaccination antibody titers at 12 months of age."}
• {"endpoint_text":"- costs- and cost-effectiveness","definition_or_measurement_approach":"Economic evaluation assessing costs and cost-effectiveness of bacterial lysate treatment regimens."}

Methods

• Recruitment arrangements: 'K2_Recruitment material Flyer' (recruitment flyer) associated with Netherlands sites (e.g. Medisch Centrum Twente) as indicated in submitted recruitment documents.
• Site-based recruitment at participating hospitals/clinics (example site: Sint Franciscus Vlietland Groep Stichting, Pediatrics department).

Netherlands

Earliest CTIS Part Ii Submission Date

04-12-2024

Latest Decision Or Authorization Date

05-12-2024

Processing Time Days

1

Number Of Sites

1

Number Of Participants

500

Primary sponsor

Full Name

Sint Franciscus Vlietland Groep Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Switzerland","full_name":"OM Pharma","duties_or_roles":"in kind","organisation_type":""}
• {"country":"Netherlands","full_name":"Longfonds Nederland","duties_or_roles":"monetary support","organisation_type":""}
• {"country":"Finland","full_name":"Ventica","duties_or_roles":"in kind","organisation_type":""}