Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
NCT ID: NCT04124055
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
51 participants
INTERVENTIONAL
2019-09-24
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Methods:
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Therapeutic drug monitoring (TDM)
Therapeutic drug monitoring (TDM) based on Saliva and Dried blood spot samples
Therapeutic drug monitoring (TDM)
Saliva and dried blood spot samples are collected. Based on the measured drug concentration the dose can be adjusted
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therapeutic drug monitoring (TDM)
Saliva and dried blood spot samples are collected. Based on the measured drug concentration the dose can be adjusted
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age of 18 years or above
Exclusion Criteria
* Co-morbid conditions such as generalized severe ulcers, Kaposi sarcoma,
* Hemophilia
* Participants with medical conditions like malignancy, dementia or those who will be critically ill and unable to consent and provide DBS and Saliva.
* Patients with Karnofsky score less than 40% or moribund
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kibong'oto Infectious Diseases Hospital
OTHER_GOV
University of Virginia
OTHER
Jan-Willem C Alffenaar
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jan-Willem C Alffenaar
prof
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stellah Mpagama, PhD
Role: PRINCIPAL_INVESTIGATOR
Kibong'oto ID hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kibong'oto infectious diseases hospital
Kibong'oto, , Tanzania
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mohamed S, Mvungi HC, Sariko M, Rao P, Mbelele P, Jongedijk EM, van Winkel CAJ, Touw DJ, Stroup S, Alffenaar JC, Mpagama S, Heysell SK. Levofloxacin pharmacokinetics in saliva as measured by a mobile microvolume UV spectrophotometer among people treated for rifampicin-resistant TB in Tanzania. J Antimicrob Chemother. 2021 May 12;76(6):1547-1552. doi: 10.1093/jac/dkab057.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-DBS-TDM-001
Identifier Type: -
Identifier Source: org_study_id