Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania

MDR-TB Clinical Trial

Official title:

Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124055
• Other study ID #: S-DBS-TDM-001
• Status: Completed
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dried blood spot and saliva samples are collected during multidrug resistant tuberculosis (MDR-TB) treatment to measure the drug concentration of levofloxacin. Feasibility of both analytical procedures in a high burdened setting is explored.

Description:

Background:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is receiving care at Kibong'oto hospital

• Age of 18 years or above

Exclusion Criteria:

• Pregnancy at any gestation

• 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

Related Conditions & MeSH terms

• MDR-TB
• Tuberculosis, Multidrug-Resistant

Intervention

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

Locations

Country	Name	City	State
Tanzania	Kibong'oto infectious diseases hospital	Kibong'oto

Sponsors (3)

Lead Sponsor	Collaborator
Jan-Willem C Alffenaar	kibong'oto Infectious diseases hospital, University of Virginia

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug exposure	Drug concentration (mgL)	>2 weeks on treatment