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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 : October 11, 2019
Sponsor:
Collaborators:
kibong'oto Infectious diseases hospital
University of Virginia
Information provided by (Responsible Party):
Jan-Willem C Alffenaar, University Medical Center Groningen

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

Condition or disease Intervention/treatment Phase
MDR-TB Diagnostic Test: TDM Not Applicable

Detailed 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 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 PoC and DBS will be calculated as a measurement of accuracy with reference to the gold standard.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: TDM
Therapeutic drug monitoring based on Saliva and Dried blood spot samples
Diagnostic Test: TDM
Saliva and dried blood spot samples are collected. Based on the measured drug concentration the dose can be adjusted




Primary Outcome Measures :
  1. Drug exposure [ Time Frame: >2 weeks on treatment ]
    Drug concentration (mgL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, demensia 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

Information from the National Library of Medicine

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


Contacts
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Contact: Jan-Willem Alffenaar, PhD +31503614071 j.w.c.alffenaar@umcg.nl

Locations
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Tanzania
Kibong'oto infectious diseases hospital Recruiting
Kibong'oto, Tanzania
Contact: Stellah Mpagama, PhD         
Sponsors and Collaborators
Jan-Willem C Alffenaar
kibong'oto Infectious diseases hospital
University of Virginia
Investigators
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Principal Investigator: Stellah Mpagama, PhD Kibong'oto ID hospital

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Responsible Party: Jan-Willem C Alffenaar, prof, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04124055     History of Changes
Other Study ID Numbers: S-DBS-TDM-001
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tuberculosis, Multidrug-Resistant
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections