{"id":"bacterial-lysates","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances (nausea, diarrhea, abdominal discomfort)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Local reactions at injection site (if parenteral formulation)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bacterial lysates are preparations containing inactivated or lysed bacteria that act as immunostimulants. They work by activating pattern recognition receptors on immune cells, promoting the production of antimicrobial peptides, immunoglobulins, and cytokines that strengthen mucosal immunity in the respiratory tract. This enhanced immune priming reduces the frequency and severity of recurrent respiratory tract infections.","oneSentence":"Bacterial lysates stimulate innate and adaptive immune responses by exposing the immune system to bacterial antigens, enhancing respiratory tract defenses and reducing infection susceptibility.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:39:43.060Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of recurrent respiratory tract infections"},{"name":"Recurrent sinusitis"},{"name":"Recurrent otitis media"}]},"trialDetails":[{"nctId":"NCT02148796","phase":"PHASE2","title":"Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness","status":"COMPLETED","sponsor":"University of Arizona","startDate":"2017-01-01","conditions":"Asthma, Wheezing","enrollment":822},{"nctId":"NCT05063149","phase":"PHASE3","title":"Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.","status":"RECRUITING","sponsor":"Franciscus Gasthuis","startDate":"2022-01-18","conditions":"Wheezing, LRTI, Premature","enrollment":500},{"nctId":"NCT05543343","phase":"NA","title":"Staphylococcus and Neisseria Tablets in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease.","status":"UNKNOWN","sponsor":"Qu Yiqing","startDate":"2022-01-05","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":495},{"nctId":"NCT05270018","phase":"NA","title":"Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP","status":"UNKNOWN","sponsor":"Sheng Wang MD PhD","startDate":"2022-03-01","conditions":"Ventilators, Mechanical","enrollment":100},{"nctId":"NCT00945087","phase":"NA","title":"Experimental Phage Therapy of Bacterial Infections","status":"UNKNOWN","sponsor":"Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences","startDate":"2005-12","conditions":"Bacterial Infections","enrollment":""},{"nctId":"NCT00599417","phase":"PHASE4","title":"PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections","status":"COMPLETED","sponsor":"Sanofi","startDate":"2007-12","conditions":"Respiratory Tract Infections","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":553,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fan fusu"],"phase":"marketed","status":"active","brandName":"Bacterial Lysates","genericName":"Bacterial Lysates","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bacterial lysates stimulate innate and adaptive immune responses by exposing the immune system to bacterial antigens, enhancing respiratory tract defenses and reducing infection susceptibility. Used for Prevention of recurrent respiratory tract infections, Recurrent sinusitis, Recurrent otitis media.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}