[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"e-coli-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:e-coli-infections":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100614515","phase-1-safety-of-combined-intravenous-antibiotic-and-bacteriophage-therapy-in-adults-with-cystic-fibrosis-and-antibiotic-resistant-lung-infections-100614515",false,"NCT07280598","Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections","Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed diagnosis of cystic fibrosis.\n* Sputum culture within 24 months and at screening showing at least one of the following: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans.\n* Percent predicted FEV₁ ≥ 40% (GLI).\n* If ppFEV₁ \\> 40%, must have ≥ 1 pulmonary exacerbation per year requiring IV antibiotics or radiographic evidence of severe disease.\n* Prior successful home IV antibiotic therapy within 5 years (may be waived by investigator).\n* Available phage cocktail with lytic activity against the participant's pathogen.\n\nOxygen saturation \\> 88% on room air after rest. Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Untreated or uncontrolled mycobacterial or fungal airway infection.\n* History of Clostridioides difficile without a negative test within 3 months. Concerning exotoxin, virulence, or resistance genes in the bacterial isolate (per investigator).\n* Mixed-species bacterial infection at screening.\n* Participation in another interventional trial within 30 days.\n* Allergy or hypersensitivity to study materials.\n* Pregnancy, planned pregnancy, or breastfeeding.\n* Any condition or abnormality that, in the investigator's judgment, makes participation unsafe or may interfere with study assessments.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1, open-label, multi-center pilot study evaluating the safety and microbiological activity of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics in adults with cystic fibrosis (CF) experiencing pulmonary exacerbations due to antibiotic-resistant bacterial infections. Eligible participants will receive a 7-day course of IV antibiotics, selected by their treating clinician, along with a phage cocktail specifically formulated to target their identified bacterial pathogen (Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans). The primary objective is to assess the safety and tolerability of this combined treatment approach. Secondary and exploratory outcomes include assessment of changes in sputum bacterial burden, lung function (spirometry and oscillometry), quality of life, and bacteriophage pharmacokinetics. Results from this study will inform the feasibility and design of future clinical trials using phage therapy in the CF population.",[26,27,28,29,30,31],"CF - Cystic Fibrosis","Klebsiella Pneumoniae Infection","E Coli Infections","Staphylococcus Aureus Infection","Achromobacter","Stenotrophomonas Maltophilia Infection",[33,34,35,36],"cystic fibrosis","CF","Phage","bacteriophage","NOT_YET_RECRUITING","2025-12-09",{"date":40,"type":41},"2025-12-12","ACTUAL",{"date":43,"type":20},"2025-12-31",{"date":45,"type":20},"2027-01-30",{"name":47,"class":48},"University of California, San Diego","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100588243","phase-1-phase-1b2a-randomized-double-blind-study-to-investigate-safety-tolerability-pk-pd-preliminary-efficacy-of-oral-administration-of-snipr001-in-patients-with-hematologic-malignancy-scheduled-for-allogeneic-hematopoietic-stem-cell-transplant-receiving-fq-prophylaxis--harboring-fqr-ecoli-pre-transplant-100588243","NCT06938867","Phase 1b\u002F2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant","A Phase 1b\u002F2a, Randomized, Double-blind Study to Investigate Safety, Tolerability, PK, PD, and Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplantation Receiving Fluoroquinolone Prophylaxis and Harboring Fluoroquinolone-Resistant Escherichia Coli Pre-Transplant","Inclusion Criteria:\n\n1. Male or female ≥18 years of age at the time of consent.\n2. Patient is able and willing to provide written informed consent prior to any study-related procedure.\n3. Confirmed diagnosis of any hematologic malignancy.\n4. Planned to undergo an allogeneic hematopoietic stem cell transplant.\n5. Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.\n6. Colonized with Fluoroquinolone resistant E. coli (patients will be pre-screened for the presence of at least 1 Fluoroquinolone resistant E. coli colony \\[cultured from a perianal swab\\] performed at the local hospital lab, qualitative assessment +\u002F-).\n7. Female patients must be of non-childbearing potential (surgically sterile or menopausal for at least 1 year) or agree to use a highly effective contraception method, per local standard, while receiving treatment with SNIPR001 and for 28 days after the last dose of SNIPR001. Male patients must utilize highly effective contraceptive precautions for the duration of SNIPR001 dosing and for 28 days after the last dose of SNIPR001.\n8. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine test on Day -2 prior to SNIPR001 dosing.\n9. Are willing to comply with all scheduled visits, laboratory tests, and other study procedures, including drinking the study medications, in the opinion of the Investigator.\n\nExclusion Criteria:\n\n1. Use of any treatment (approved or investigational product) considered to interact with the study drug, or which might impact the outcome of the study within 14 days (or 5 half-lives of the approved or investigational product, whichever is greater) prior to the first administration of study drug, as judged by the Investigator.\n2. Use or planned use of any antibiotics with intrinsic activity against E. coli in the gut (e.g., beta-lactam antibiotics) between Pre-Screening and until the end of the SNIPR001\u002Fplacebo treatment period, with the exception of TMP-SMX and levofloxacin.\n3. Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and\u002For Alka-Seltzer Gold treatment.\n4. Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.\n5. Female patients who are pregnant or lactating.\n6. Have abnormal liver enzymes (alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\] \\>2 × upper limit of normal \\[ULN\\] or total bilirubin \\>1.5 × ULN).\n7. Have hepatic disease associated with impaired liver function.\n8. Have a history of Achilles tendinopathy or tendon rupture.",{"count":57,"type":20},24,[23,59],"PHASE2","This is a Phase 1b\u002F2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC levofloxacin.",[28,62],"Allogenic Transplant Patients","RECRUITING","2025-10-09",{"date":66,"type":41},"2025-10-14",{"date":68,"type":41},"2025-02-25",{"date":70,"type":20},"2026-04-01",{"name":72,"class":73},"SNIPR Biome Aps.","INDUSTRY",8]