[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614515":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":20,"eligibilityCriteria":31,"healthyVolunteers":27,"sex":32,"minAge":33,"maxAge":20,"enrollmentInfo":34,"targetDuration":20,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":48,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":20},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 Study of Combined IV Antibiotics and Bacteriophage Therapy for Antibiotic-Res","EXPERIMENTAL","This arm will evaluate the safety and microbiological activity of a combined intravenous (IV) antibiotic and bacteriophage therapy in adults with cystic fibrosis (CF) who are experiencing pulmonary exacerbations caused by antibiotic-resistant bacterial pathogens. Participants will receive a clinician-selected, standard IV antibiotic regimen for 7 days, administered twice daily. In parallel, participants will receive a matched, pathogen-specific bacteriophage cocktail via IV infusion, also administered twice daily for 7 days. The phage cocktails consist of four lytic bacteriophages targeting one of the following pathogens: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans. The first three phage doses will be administered in a monitored clinic setting; remaining doses will be self-administered at home via PICC line. This is a Phase 1, open-label, multi-site pilot study focused on safety.",[13],"Drug: Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics","Participants will receive a seven-day course of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics. The bacteriophage therapy consists of a pathogen-specific cocktail containing four purified, lytic bacteriophages selected based on pre-treatment sensitivity testing of the participant's bacterial isolate. Each phage cocktail targets one of the following antibiotic-resistant pathogens: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans. Phage cocktails are administered IV twice daily at a concentration of 1x10⁹ PFU\u002FmL, following antibiotic infusion. The first three doses are observed in clinic; remaining doses are self-administered at home via PICC line. All phages are produced under GMP conditions and screened to be lytic-only, free of known toxin, resistance, or lysogeny genes.",[9],null,{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","David Pride","Director of the Clinical Molecular Microbiology Laboratory","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":35,"type":36},30,"ESTIMATED","INTERVENTIONAL",[39],"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.",[42,43,44,45,46,47],"CF - Cystic Fibrosis","Klebsiella Pneumoniae Infection","E Coli Infections","Staphylococcus Aureus Infection","Achromobacter","Stenotrophomonas Maltophilia Infection",[49,50,51,52],"cystic fibrosis","CF","Phage","bacteriophage","NOT_YET_RECRUITING","2025-12-09",{"date":56,"type":57},"2025-12-12","ACTUAL",{"date":59,"type":36},"2025-12-31",{"date":61,"type":36},"2027-01-30",{"name":5,"class":6}]