Status:
COMPLETED
Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
Lead Sponsor:
Jan-Willem C Alffenaar
Collaborating Sponsors:
Kibong'oto Infectious Diseases Hospital
University of Virginia
Conditions:
MDR-TB
Eligibility:
All Genders
18+ years
Phase:
NA
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 procedure...
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 acqui...
Eligibility Criteria
Inclusion
- Participant is receiving care at Kibong'oto hospital
- Age of 18 years or above
Exclusion
- 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
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04124055
Start Date
September 24 2019
End Date
December 31 2019
Last Update
October 30 2020
Active Locations (1)
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1
Kibong'oto infectious diseases hospital
Kibong'oto, Tanzania