Trial reportNature communications2025
Phage therapy with nebulized cocktail BX004-A for chronic Pseudomonas aeruginosa infections in cystic fibrosis: a randomized first-in-human trial.
Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05010577 (A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis), which is not on this map. Cited by 26 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary Infection
Who cites it
26 citing papers in PubMed.
- Anti-phage defense systems in bacteria: molecular mechanisms and their role in shaping phage therapy strategies.Molecular biology reports · 2026Review
- Phage Genomics and Bioinformatics in Therapeutic Development: Evidence Limits, Validation Gates, and Translational Decision-Making.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Non-Traditional Antibacterial Agents Relevant to the WHO 2024 Priority Pathogens: A Structured Update of the Clinical Pipeline.Antibiotics (Basel, Switzerland) · 2026Review
- Approaching the post-antibiotic era: phage therapy current practices and future horizons.mBio · 2026Review
- Antibodies targeting phage fiber and nozzle proteins impair Acinetobacter baumannii phage therapy by blocking infection and promoting immune clearance.PLoS biology · 2026Article
- Pharmacology of Bacteriophage Therapy in Children: A Re-Emerging Paradigm in Antibacterial Therapy.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Characterization and antibacterial efficacy of the broad-host-range phage P108 against biofilm-forming and methicillin-resistant Staphylococcus aureus.Virus research · 2026Article
- Host-Pathogen Interactions in Cystic Fibrosis Lung Disease: Adaptation, Persistence, and Clinical Implications ofPathogens (Basel, Switzerland) · 2026Review
- Efficacy and Safety Outcomes of Bacteriophage Therapy for Resistant Bacterial Infections.Cureus · 2026Review
- Quorum Sensing and Quorum Quenching in Pseudomonas aeruginosa and Staphylococcus aureus Infections: Therapeutic Potential, Limitations and Clinical Challenges.Antibiotics (Basel, Switzerland) · 2026Review
- Bacteriophages as Therapeutic Agents for Pulmonary Infections: From Biological Principles to Clinical Applications.Pharmaceutics · 2026Review
- Ecological partitioning enables phage-antibiotic cooperation in a human Pseudomonas infection.Nature communications · 2026Article
- GlnK Regulates the Type III Secretion System by Modulating NtrB-NtrC Homeostasis inMicroorganisms · 2026Article
- Phage-Based Approaches to ChronicAntibiotics (Basel, Switzerland) · 2026Review
- Bacteriophage Therapy AgainstMicroorganisms · 2026Review
- Hospital-adapted inhaled phage therapy for ventilator-associated pneumonia caused by multidrug-resistant Klebsiella pneumoniae: a comparative pilot study.Critical care (London, England) · 2026Article
- The respiratory microbiome influences the occurrence of respiratory diseases in children.Frontiers in pediatrics · 2026Review
- Bacteriophage Therapy in Cystic Fibrosis: Emerging Strategies for Managing ChronicDrug design, development and therapy · 2026Review
- Genomic and functional characterization ofFrontiers in microbiology · 2026Article
- Targeting biofilm-driven antibiotic resistance: emerging mechanisms and next-generation therapeutic interventions.Frontiers in microbiology · 2026Review
Corrections and comments
- Erratum issued
Authors and funding
44 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Cystic fibrosis is a monogenetic disease complicated by recurrent bacterial lung infections that require chronic antibiotics. Pseudomonas aeruginosa is an increasingly antibiotic-resistant pathogen associated with cystic fibrosis morbidity and mortality. Here, we describe the development of a three-phage cocktail (BX004-A) designed to target a wide range of P. aeruginosa strains. We evaluated BX004-A in Part 1 of a first-in-human double-blind placebo-controlled phase 1b/2a clinical trial, which included nine adult cystic fibrosis patients chronically infected with P. aeruginosa (NCT05010577). BX004-A met the primary endpoints of safety and tolerability. Exploratory endpoints included pharmacokinetics and Pseudomonas aeruginosa sputum density reduction. Efficient phage delivery to the lower respiratory tract was observed, and a potential reduction in P. aeruginosa sputum burden was noted in the phage arm. However, due to the study's small sample size, definitive conclusions regarding efficacy are limited. These data pave the way toward further development of novel phage-based therapeutics in antibiotic-resistant pulmonary bacterial infections.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.