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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with Nontuberculous Mycobacterial (NTM) disease who are considered for treatment with phage therapy will be recruited. Those that have a positive match for their NTM isolate and starts on mycobacteriophage treatment will be considered cases while those that do not have a positive match and/or does not start on mycobacteriophage treatment will be considered controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bacteriophage Treatment
Biological/VaccineParticipants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Participants receiving phage therapy1 intervention
Group B: Participants not receiving phage therapy0 interventions
Trial outcomes
Primary outcomes
1
Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement
Improvement 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.
Time frame
End of study (up to 2 years)Secondary outcomes
1
Biomarkers associated with the development of neutralization antibodies
Time frame
End of study (up to 2 years)Sponsors and contacts
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Source ClinicalTrials.gov