Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
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|ClinicalTrials.gov Identifier: NCT04124055|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|MDR-TB||Diagnostic Test: Therapeutic drug monitoring (TDM)||Not Applicable|
Measuring pharmacokinetic variability of anti-tuberculosis (TB) drugs and responding by dose correction will allow individualized treatment to improve microbiological response, curb acquired drug-resistance, protect and extend the efficacy of novel drugs rolled-out to endemic areas (pharmacovigilance), reduce toxicity to patients and lead to treatment duration shortening.
Aims and Objectives:
Implement Dried Blood Spot (DBS) collection for performance of high-performance liquid chromatography (HPLC) to optimize multidrug resistant TB (MDR-TB) treatment in Tanzania. Simultaneously, provide a proof-of-principle-demonstration that the developed saliva point of care drug assay for measurement of fluoroquinolone concentration works in a field setting.
This will be a phase II prospective diagnostic study among patients from a national referral of MDR-TB in Tanzania. The investigators anticipate recruiting a minimum of 50 study participants to power for the primary aim. Subjects will have a minimum amount of blood and saliva collected for therapeutic drug monitoring and the investigational drug assays respectively. Expected results include agreement of saliva point-of-care and DBS for measurement of fluoroquinolone concentrations in HPLC. Other important findings related to field-testing include the best time for sample collection within the dosing interval and the algorithmic use of DBS and saliva, and clinical - demographic factors such as HIV coinfection, concomitant drugs, and diabetes mellitus that may influence the saliva drug assay results. Performance characteristics (sensitivity, specificity, negative and positive predictive values) of the saliva point-of care (PoC) and DBS will be calculated as a measurement of accuracy with reference to the gold standard.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania|
|Actual Study Start Date :||September 24, 2019|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Therapeutic drug monitoring (TDM)
Therapeutic drug monitoring (TDM) based on Saliva and Dried blood spot samples
Diagnostic Test: Therapeutic drug monitoring (TDM)
Saliva and dried blood spot samples are collected. Based on the measured drug concentration the dose can be adjusted
- Drug exposure [ Time Frame: >2 weeks on treatment ]Drug concentration (mgL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124055
|Contact: Jan-Willem Alffenaar, PhDemail@example.com|
|Kibong'oto infectious diseases hospital||Recruiting|
|Contact: Stellah Mpagama, PhD|
|Principal Investigator:||Stellah Mpagama, PhD||Kibong'oto ID hospital|