PK and PD of Antibiotics for Treatment of Mycobacterium Abscessus Pulmonary Disease
Pharmacokinetics and Pharmacodynamics of Multidrug-regimens for Mycobacterium Abscessus Pulmonary Disease
1 other identifier
observational
40
0 countries
N/A
Brief Summary
Investigating the PK and PD indices in patients with M. abscessus complex-PD who will be treated with a currently recommended regimen, minimum inhibitory concentrations of organism, and their relation with clinical outcomes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedFirst Posted
Study publicly available on registry
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 9, 2023
December 1, 2022
2 years
December 8, 2022
December 22, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Peak concentration (Cmax)
Cmax of guideline-recommended antibiotics in patients will be measured
2 weeks of treatment
Time to Cmax
Time to Cmax of guideline-recommended antibiotics in patients will be measured
2 weeks of treatment
Area under the curve from 0 to 24 hours after dosing
AUC24 of guideline-recommended antibiotics in patients will be measured
2 weeks of treatment
Plasma half-life
Plasma half-life of guideline-recommended antibiotics in patients will be measured
2 weeks of treatment
Secondary Outcomes (2)
Time to culture positivity (days) by AUC24 (mg x h/L)
2 weeks of treatment
Time to culture positivity (days) by Cmax (mg /L)
2 weeks of treatment
Interventions
Measuring plasma concentration of commonly used antibiotics in NTM-PD
Eligibility Criteria
Patients with M. abscessus pulmonary disease, who receive conventional antibiotic treatment based on the currently recommended guideline.
You may qualify if:
- Age 20 years old or more
- Fulfilling the criteria of NTM-PD (1, 13), for which causative organism belongs to M. abscessus or M. massiliense
- Needing a new antibiotic treatment for M. abscessus complex-PD due to symptomatic aggravation, radiographic progression or both (those who have previous history of treatment are eligible)
- Consenting to receive antibiotic treatment based on currently recommended regimens (1, 13) and to participate in this study
You may not qualify if:
- Receiving any treatment for NTM-PD within 4 weeks
- Having end-stage renal disease needing hemodialysis, chronic liver disease, or active malignancy needing treatment during the treatment period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Joon Yim, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 8, 2022
First Posted
January 9, 2023
Study Start
January 1, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 9, 2023
Record last verified: 2022-12