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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.
 
ClinicalTrials.gov Identifier: NCT04124055
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : December 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

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE September 24, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
Drug exposure [ Time Frame: >2 weeks on treatment ]
Drug concentration (mgL)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04124055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
Official Title  ICMJE Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
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.
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 (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE MDR-TB
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Therapeutic drug monitoring (TDM)
Therapeutic drug monitoring (TDM) based on Saliva and Dried blood spot samples
Intervention: Diagnostic Test: Therapeutic drug monitoring (TDM)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan-Willem Alffenaar, PhD +31503614071 j.w.c.alffenaar@umcg.nl
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124055
Other Study ID Numbers  ICMJE S-DBS-TDM-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jan-Willem C Alffenaar, University Medical Center Groningen
Study Sponsor  ICMJE Jan-Willem C Alffenaar
Collaborators  ICMJE
  • kibong'oto Infectious diseases hospital
  • University of Virginia
Investigators  ICMJE
Principal Investigator: Stellah Mpagama, PhD Kibong'oto ID hospital
PRS Account University Medical Center Groningen
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP