{"id":"cefepime-aai101-combination","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"5-15%","effect":"Vomiting"},{"rate":"5-10%","effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Cefepime is a fourth-generation cephalosporin antibiotic that has a broad spectrum of activity against Gram-positive and Gram-negative bacteria. AAI101 is a beta-lactamase inhibitor that prevents bacterial resistance to cefepime by inhibiting the action of beta-lactamase enzymes.","oneSentence":"Cefepime/AAI101 combination is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:05:18.384Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Complicated urinary tract infections"},{"name":"Nosocomial pneumonia"}]},"trialDetails":[{"nctId":"NCT03680352","phase":"PHASE1","title":"Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects","status":"COMPLETED","sponsor":"Allecra","startDate":"2017-09-01","conditions":"PK in Patients With Various Degrees of Renal Impairment","enrollment":30},{"nctId":"NCT03680378","phase":"PHASE1","title":"Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)","status":"COMPLETED","sponsor":"Allecra","startDate":"2017-07-01","conditions":"Healthy Subjects","enrollment":19},{"nctId":"NCT03687255","phase":"PHASE3","title":"Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections","status":"COMPLETED","sponsor":"Allecra","startDate":"2018-09-24","conditions":"Urinary Tract Infections","enrollment":1043},{"nctId":"NCT03685084","phase":"PHASE1","title":"Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers","status":"COMPLETED","sponsor":"Allecra","startDate":"2013-10-10","conditions":"Healthy","enrollment":56},{"nctId":"NCT03680612","phase":"PHASE2","title":"Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI","status":"COMPLETED","sponsor":"Allecra","startDate":"2017-09-05","conditions":"Urinary Tract Infections","enrollment":45}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"cefepime/AAI101 combination","genericName":"cefepime/AAI101 combination","companyName":"Allecra","companyId":"allecra","modality":"Small molecule","firstApprovalDate":"","aiSummary":"The cefepime/AAI101 combination is being studied for the treatment of complicated urinary tract infections, as seen in a Phase 3 clinical trial (NCT03687255) registered on ClinicalTrials.gov. Cefepime, a small molecule antibiotic, is combined with AAI101 in this treatment, according to information on ClinicalTrials.gov and ChEMBL.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}