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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04124055
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : December 11, 2019
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 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.

Condition or disease Intervention/treatment Phase
MDR-TB Diagnostic Test: Therapeutic drug monitoring (TDM) Not Applicable

Detailed Description:


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.

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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 : December 15, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT04124055

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Contact: Jan-Willem Alffenaar, PhD +31503614071

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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
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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 Identifier: NCT04124055    
Other Study ID Numbers: S-DBS-TDM-001
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 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
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections