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NCT04124055
Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
NA trial testing Therapeutic drug monitoring (TDM) in MDR-TB in 51 participants. Completed in 31 December 2019.
15 December 2019
Quick facts
| Lead sponsor | Jan-Willem C Alffenaar |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 24 September 2019 |
| Primary completion | 15 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across Tanzania |
Drugs / interventions tested
- Therapeutic drug monitoring (TDM)
Conditions studied
- MDR-TB — all drugs for MDR-TB →
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):
-
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 -
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:
- PubMed search for NCT04124055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Therapeutic drug monitoring (TDM)
Trials testing the same drug.
- NCT05460390 — Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis · NA · terminated
Other recruiting trials for MDR-TB
Currently open trials in the same condition.
- NCT05493267 — A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04124055 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jan-Willem C Alffenaar
- Last refreshed: 30 October 2020
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