About this trial
This study aims to identify biomarkers associated with response to phage therapy for refractory bacterial infections. This includes mycobacteriophage treatment for patients with nontuberculous mycobacterial infections. Blood and airway samples will be obtained from follow up visits of patients with refractory bacterial infections that are considered for phage therapy. Samples will be compared between those that receive phage therapy and those that did not. Biomarkers will include changes in the airway microbiome, transcriptome, inflammatory cytokines, and development of neutralizing antibody against phages. The primary endpoint is to identify biomarkers associated with clinical and/or radiographic improvement and/or culture improvement which includes clearing of cultures or decrease in qualitative or resolution of signs and symptoms of infection after at least 6-8 weeks of bacteriophage therapy.
Eligibility criteria
Qualifiers
Adults 18 years of age or older
Provision of appropriate written consent
Willingness and ability to participate in study procedures
Diagnosis of bacterial/mycobacterial infection that meets criteria for treatment (clinical, radiographic, and microbiologic data)
Disqualifiers
Patients under 18 years of age
Pregnant individuals as this population is not considered for phage treatment due to unknown risks of the treatment
Breastfeeding Individuals who are breastfeeding as this population is not considered for phage treatment due to unknown risk to the infant
Trial design
Treatments tested in this trial
- Bacteriophage Treatment