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NCT04124055

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

Completed NA Last updated 30 October 2020
What this trial tests

NA trial testing Therapeutic drug monitoring (TDM) in MDR-TB in 51 participants. Completed in 31 December 2019.

Timeline
24 September 2019
Primary endpoint
15 December 2019
31 December 2019

Quick facts

Lead sponsorJan-Willem C Alffenaar
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment51
Start date24 September 2019
Primary completion15 December 2019
Estimated completion31 December 2019
Sites1 location across Tanzania

Drugs / interventions tested

Conditions studied

Sponsor

Jan-Willem C Alffenaar — full company profile →

Who can join

18 and older, any sex, with MDR-TB. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Levofloxacin pharmacokinetics in saliva as measured by a mobile microvolume UV spectrophotometer among people treated for rifampicin-resistant TB in Tanzania.
    Mohamed S, Mvungi HC, Sariko M, Rao P, et al · · 2021 · cited 17× · PMID 33675664 · DOI 10.1093/jac/dkab057
  2. Therapeutic drug monitoring (TDM) as intervention: A cross-sectional analysis of characteristics of 173 registered clinical trials.
    Zhao S, Zaytseva O, Chang X, Zhang B. · · 2022 · cited 4× · PMID 36276264 · DOI 10.1016/j.conctc.2022.101014

Verify or expand the search:

Other trials of Therapeutic drug monitoring (TDM)

Trials testing the same drug.

Other recruiting trials for MDR-TB

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04124055.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing