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Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection

ConditionsMycobacterium Abscessus InfectionBacteriophage TherapyPulmonary Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlberta Health services

About this trial

The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consent to participation

Disqualifiers

non-consent to participation

Trial design

Design model

Single group

Treatments tested in this trial

  • DP-QB-MYA-002

    Biological/Vaccine

    In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss

Treatment groups

1 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to Sputum Culture Conversion (Microbiologic Response)

Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment

Time frame
1 year

Secondary outcomes

1

Change in Volume of Sputum Production (Clinical Response)

Patient Report

Time frame
1 year
2

Change in frequency of Cough (Clinical Response)

Patient Report

Time frame
1 year
3

Change in FEV1 (Clinical Response)

This will be assessed via spirometry at baseline and at the end of the study An increase in FEV1 indicating improvement in lung function or FEV1 decrease indicating decline in lung function.

Time frame
1 year
4

Change in BMI (Clinical Response)

Within subject change in BMI measured in kg/m\^2. Increase in BMI as a sign of improvement. Decline in BMI as sign of decline or worse outcome.

Time frame
1 year

Other outcomes

1

Adverse Effects (Clinical)

Adverse clinical and laboratory events (number and severity) on treatment

Time frame
1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alberta Health services

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: