Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2019
CompletedFirst Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedOctober 30, 2020
October 1, 2020
3 months
October 9, 2019
October 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Drug exposure
Drug concentration (mgL)
>2 weeks on treatment
Study Arms (1)
Therapeutic drug monitoring (TDM)
EXPERIMENTALTherapeutic drug monitoring (TDM) based on Saliva and Dried blood spot samples
Interventions
Saliva and dried blood spot samples are collected. Based on the measured drug concentration the dose can be adjusted
Eligibility Criteria
You may qualify if:
- Participant is receiving care at Kibong'oto hospital
- Age of 18 years or above
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jan-Willem C Alffenaarlead
- Kibong'oto Infectious Diseases Hospitalcollaborator
- University of Virginiacollaborator
Study Sites (1)
Kibong'oto infectious diseases hospital
Kibong'oto, Tanzania
Related Publications (1)
Mohamed S, Mvungi HC, Sariko M, Rao P, Mbelele P, Jongedijk EM, van Winkel CAJ, Touw DJ, Stroup S, Alffenaar JC, Mpagama S, Heysell SK. Levofloxacin pharmacokinetics in saliva as measured by a mobile microvolume UV spectrophotometer among people treated for rifampicin-resistant TB in Tanzania. J Antimicrob Chemother. 2021 May 12;76(6):1547-1552. doi: 10.1093/jac/dkab057.
PMID: 33675664DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stellah Mpagama, PhD
Kibong'oto ID hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- prof
Study Record Dates
First Submitted
October 9, 2019
First Posted
October 11, 2019
Study Start
September 24, 2019
Primary Completion
December 15, 2019
Study Completion
December 31, 2019
Last Updated
October 30, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share