{"doi":"10.1093/cid/ciad335","title":"A Retrospective, Observational Study of 12 Cases of Expanded-Access Customized Phage Therapy: Production, Characteristics, and Clinical Outcomes","abstract":"BACKGROUND: Antimicrobial resistance (AMR) is undermining modern medicine, a problem compounded by bacterial adaptation to antibiotic pressures. Phages are viruses that infect bacteria. Their diversity and evolvability offer the prospect of their use as a therapeutic solution. Reported are outcomes of customized phage therapy for patients with difficult-to-treat antimicrobial resistant infections. METHODS: We retrospectively assessed 12 cases of customized phage therapy from a phage production center. Phages were screened, purified, sequenced, characterized, and Food and Drug Administration-approved via the IND (investigational new drug) compassionate-care route. Outcomes were assessed as favorable or unfavorable by microbiologic and clinical standards. Infections were device-related or systemic. Other experiences such as time to treatment, antibiotic synergy, and immune responses were recorded. RESULTS: Fifty requests for phage therapy were received. Customized phages were generated for 12 patients. After treatment, 42% (5/12) of cases showed bacterial eradication and 58% (7/12) showed clinical improvement, with two-thirds of all cases (66%) showing favorable responses. No major adverse reactions were observed. Antibiotic-phage synergy in vitro was observed in most cases. Immunological neutralization of phages was reported in 5 cases. Several cases were complicated by secondary infections. Complete characterization of the phages (morphology, genomics, and activity) and their production (methods, sterility, and endotoxin tests) are reported. CONCLUSIONS: Customized phage production and therapy was safe and yielded favorable clinical or microbiological outcomes in two-thirds of cases. A center or pipeline dedicated to tailoring the phages against a patient's specific AMR bacterial infection may be a viable option where standard treatment has failed.","journal":"Clinical Infectious Diseases","year":2023,"id":316720,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":94,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9524,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":465023,"name":"Justin R. Clark","orcid":"0000-0003-1590-6828","position":1,"is_corresponding":false},{"id":1020992,"name":"Haroldo Hernandez Santos","orcid":"0009-0009-6005-7619","position":2,"is_corresponding":false},{"id":1021840,"name":"Kyle Weesner","orcid":null,"position":3,"is_corresponding":false},{"id":683377,"name":"Keiko C. Salazar","orcid":"0000-0002-1845-281X","position":4,"is_corresponding":false},{"id":645873,"name":"Saima Aslam","orcid":"0000-0002-4051-5629","position":5,"is_corresponding":false},{"id":21027,"name":"J Campbell","orcid":null,"position":6,"is_corresponding":false},{"id":264777,"name":"Sarah B. Doernberg","orcid":"0000-0003-1727-6014","position":7,"is_corresponding":false},{"id":1021841,"name":"Emily Blodget","orcid":null,"position":8,"is_corresponding":false},{"id":501018,"name":"Michele I. Morris","orcid":"0000-0002-4479-8726","position":9,"is_corresponding":false},{"id":239772,"name":"Gina A. Suh","orcid":"0000-0001-7434-6897","position":10,"is_corresponding":false},{"id":1020993,"name":"Karam M. Obeid","orcid":"0000-0002-4131-647X","position":11,"is_corresponding":false},{"id":335126,"name":"Fernanda P. Silveira","orcid":"0000-0002-1473-0878","position":12,"is_corresponding":false},{"id":858644,"name":"Andrey A. Filippov","orcid":"0000-0003-2256-861X","position":13,"is_corresponding":false},{"id":237261,"name":"Katrine Whiteson","orcid":"0000-0002-5423-6014","position":14,"is_corresponding":false},{"id":276984,"name":"Barbara W. Trautner","orcid":"0000-0001-7986-9099","position":15,"is_corresponding":false},{"id":426283,"name":"Austen Terwilliger","orcid":"0000-0001-8740-0290","position":16,"is_corresponding":false},{"id":363659,"name":"Anthony W. Maresso","orcid":"0000-0002-4452-3490","position":17,"is_corresponding":false},{"id":426284,"name":"Sabrina I. Green","orcid":"0000-0003-3959-2640","position":0,"is_corresponding":true}],"reference_count":33,"raw_metadata":null,"created_at":"2026-07-19T01:06:44.698773Z","pmid":"37279523","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}