[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"achromobacter\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:achromobacter":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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"]