Streptococcus agalactiae; Haemophilus influenzae; Staphylococcus aureus; Streptococcus pneumoniae for Recurrent lower respiratory tract infections

Inclusion criteria

• {"criterion_text":"- Patients willing and able to provide voluntary informed consent and to follow protocol requirements."}
• {"criterion_text":"- Male or females from 18 to 99 years old, (Adult, Older Adult)"}
• {"criterion_text":"- Patients with Recurrent LRTIs including tracheitis, tracheobronchitis, acute bronchitis and exacerbations of chronic lung disease (asthma and/or COPD and/or bronchiectasis), who present with both of the following: a. ≥2 episodes within 12 months prior to the run-in period based on patient reported medical history (to access the run-in period) b. ≥2 episodes during the run-in period documented by appropriate microbiological diagnostic test (to access the treatment period)"}
• {"criterion_text":"- Patients: a. Not vaccinated Or b. Vaccinated against the most common pathogens for respiratory infection (within 12 months prior to the run-in period or during the run-in period, but not during the treatment period): - Anti-pertussis vaccination - Covid-19 vaccination - Respiratory Syncytial Virus vaccination - Influenza vaccination - Pneumococcal vaccination"}

Exclusion criteria

• {"criterion_text":"- Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test)."}
• {"criterion_text":"- Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol."}
• {"criterion_text":"- Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study."}
• {"criterion_text":"- Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients."}
• {"criterion_text":"- Pneumonia (based on the EMA Referral Procedure EMEA/H/A-31/1465)."}
• {"criterion_text":"- Known history of tuberculosis and/or cystic fibrosis."}
• {"criterion_text":"- Known history of immunodeficiency diseases (e.g., HIV infection, AIDS, or any type of congenital or iatrogenic immune deficiency, including IgA deficiency)."}
• {"criterion_text":"- Severe heart failure (NYHA class III and IV)."}
• {"criterion_text":"- Haematologic diseases including severe anaemia (defined according to the National Cancer Institute as Hemoglobin < 8.0 g/dL)."}
• {"criterion_text":"- Renal failure (eGFR < 30 mL/min)."}
• {"criterion_text":"- History of autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC."}
• {"criterion_text":"- History of known liver damages defined by the METAVIR classification (F1-F4)."}
• {"criterion_text":"- Malignancies with a remission period of < 5 years."}
• {"criterion_text":"- Injection or oral administration of steroids within 4 weeks prior to randomization."}
• {"criterion_text":"- Use of immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to randomization."}
• {"criterion_text":"- Previous use within 6 months prior to randomization or ongoing use of bacterial lysates."}
• {"criterion_text":"- Any major surgery within the last 3 months prior to randomization."}
• {"criterion_text":"- Wheezing documented to be caused by gastroesophageal reflux."}
• {"criterion_text":"- Patient legally or mentally incapacitated unable to give informed consent for the participation in this study."}

Primary endpoints

• {"endpoint_text":"- Reduction in the number of infection episodes in the treatment period (12 months) in the Buccalin® group versus the Placebo group.","definition_or_measurement_approach":"Number of infection episodes during the 12-month treatment period compared between Buccalin and Placebo groups."}

Secondary endpoints

• {"endpoint_text":"- Reduction in the number of infection episodes during 3, 6 and 9 months of treatment will be assessed.","definition_or_measurement_approach":"Number of infection episodes assessed at 3, 6 and 9 months during treatment."}
• {"endpoint_text":"- Mean duration in days per RLRTI during the Treatment period and during the Follow up period will be assessed.","definition_or_measurement_approach":"Mean number of days per recurrent lower respiratory tract infection episode during treatment and follow-up."}
• {"endpoint_text":"- Number of antibiotic treatments for a respiratory event during the Treatment period and during the Follow-up period will be assessed.","definition_or_measurement_approach":"Count of antibiotic courses for respiratory events during treatment and follow-up."}
• {"endpoint_text":"- Number of sick days for patients or caregiver during the Treatment period and during the Follow-up period will be assessed.","definition_or_measurement_approach":"Number of work/school days lost by patient or caregiver recorded during treatment and follow-up."}
• {"endpoint_text":"- During the treatment period the patients were asked to fill in a Visual Analogue Scale (VAS) ranging from 0 (the worse) to 10 (the best situation).","definition_or_measurement_approach":"Patient-reported VAS score (0–10) collected during treatment period."}
• {"endpoint_text":"- Quantitative and Qualitative Evaluation of Safety in terms of adverse events reported.","definition_or_measurement_approach":"Safety evaluation via reporting and analysis of adverse events (qualitative and quantitative)."}

Italy

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

06-08-2025

Processing Time Days

317

Number Of Sites

9

Number Of Participants

216

North Macedonia

Number Of Participants

24

Primary sponsor

Full Name

Laboratorio Farmaceutico S.I.T. - Specialita' Igienico Terapeutiche S.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Crolife S.r.l.","duties_or_roles":"Codes: 1,10,11,12,13,2,5,6,7 (as listed in sponsorDuties)","organisation_type":"Pharmaceutical company"}