Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585358
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-13
Brief Title:
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DoseTB
Brief Summary:
The goal of this observational study is to investigate whether model-informed precision dosing MIPD as a clinical support for early individualised dosing in addition to the national TB care program can optimise the drug exposure of TB drugs during TB treatment
Main research questions
In adult patients with drug-susceptible pulmonary tuberculosis can the use of current dose recommendations and information received from MIPD help clinicians in a timely manner to optimise the drug exposure of TB drugs in the early treatment phase ie time from PK sampling to dose adjustment keep or adjust dose
Specific aims
I To perform a process evaluation of early MIPD for rifampicin isoniazid pyrazinamide and ethambutol during active TB treatment
II To study the target attainment of first-line TB drugs with MIPD
III To evaluate model precision of predicted versus detected drug concentrations
Drug concentrations will be measured in study participants during TB treatment and drug exposure and optimal dose predicted by MIPD using pharmacokinetic population models
Main research questions
In adult patients with drug-susceptible pulmonary tuberculosis can the use of current dose recommendations and information received from MIPD help clinicians in a timely manner to optimise the drug exposure of TB drugs in the early treatment phase ie time from PK sampling to dose adjustment keep or adjust dose
Specific aims
I To perform a process evaluation of early MIPD for rifampicin isoniazid pyrazinamide and ethambutol during active TB treatment
II To study the target attainment of first-line TB drugs with MIPD
III To evaluate model precision of predicted versus detected drug concentrations
Drug concentrations will be measured in study participants during TB treatment and drug exposure and optimal dose predicted by MIPD using pharmacokinetic population models
Detailed Description:
Background
Individualised treatment for tuberculosis TB to improve treatment outcome has still some substantial obstacles to pass before becoming a reality in clinical practice Previous studies including studies from the study research group have shown that lower than recommended drug concentrations of TB drugs are common and affect treatment outcome Despite this lower than recommended doses are often prescribed by clinicians Adequate drug doses should be ensured as early as possible in the intensive phase when the bacterial load is high Simple therapeutic drug monitoring TDM at the time of steady state of TB drugs are used in many clinical settings today but time to dose adjustments to avoid suboptimal drug levels is typically several weeks However pharmacokinetic models are in place to guide individualised drug dosing by Model-Informed Precision Dosing MIPD already from the first days of treatment MIPD in combination with currently recommended dose recommendations can be used to derive the most efficacious and safe dose for a patient A similar approach has been implemented for dosing of vancomycin in children but has not been used in a clinical setting in the field of TB This study will evaluate the logistics and dose regimens when clinicians are given the current dose recommendations of the first line drugs rifampicin isoniazid and pyrazinamide as well as the results of the MIPD for patients with active pulmonary TB
Individualised treatment for tuberculosis TB to improve treatment outcome has still some substantial obstacles to pass before becoming a reality in clinical practice Previous studies including studies from the study research group have shown that lower than recommended drug concentrations of TB drugs are common and affect treatment outcome Despite this lower than recommended doses are often prescribed by clinicians Adequate drug doses should be ensured as early as possible in the intensive phase when the bacterial load is high Simple therapeutic drug monitoring TDM at the time of steady state of TB drugs are used in many clinical settings today but time to dose adjustments to avoid suboptimal drug levels is typically several weeks However pharmacokinetic models are in place to guide individualised drug dosing by Model-Informed Precision Dosing MIPD already from the first days of treatment MIPD in combination with currently recommended dose recommendations can be used to derive the most efficacious and safe dose for a patient A similar approach has been implemented for dosing of vancomycin in children but has not been used in a clinical setting in the field of TB This study will evaluate the logistics and dose regimens when clinicians are given the current dose recommendations of the first line drugs rifampicin isoniazid and pyrazinamide as well as the results of the MIPD for patients with active pulmonary TB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None