Biomarkers of Phage Treatment Response in NTM and Other Infections

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNYU Langone Health

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

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators