drugset / Trial / NCT04081077
PRACTECAL-PKPD Sub Study
Phase 2/3
Unknown
240 enrolled
Medecins Sans Frontieres, Netherlands
Drugs for Neglected Diseases · collabGlobal Alliance for TB Drug Development · collabHackensack Meridian Health · collabLondon School of Hygiene and Tropical Medicine · collabMinistry of Health, Republic of Uzbekistan · collabMinistry of Public Health, Republic of Belarus · collabMinsk Republican Research and Practical Centre for Pulmonology and Tuberculosis · collabSwiss Tropical & Public Health Institute · collabTHINK TB & HIV Investigative Network · collabUniversity College, London · collabUniversity of California, San Francisco · collabUniversity of Liverpool · collabWits Health Consortium (Pty) Ltd · collabWorld Health Organization · collabeResearch Technology, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and their respective treatment outcomes.
Timeline
- Start
- 2019-08-06
- Primary completion
- 2022-09-30
- Completion
- 2022-09-30
Publications
- Nyang'wa BT, Motta I, Moodliar R, Solodovnikova V, Rajaram S, Rasool M, Berry C, Moore DAJ, Davies G, Kloprogge F. Pharmacokinetics, bactericidal activity and toxicity of short oral regimens for rifampicin-resistant tuberculosis treatment. Nat Commun. 2026 Jun 10. doi: 10.1038/s41467-026-74335-y. Online ahead of print.
- Nyang'wa BT, Motta I, Moodliar R, Solodovnikova V, Rajaram S, Rasool M, Berry C, Huang Z, Davies G, Moore DAJ, Kloprogge F. Population pharmacokinetics and target attainment of pretomanid in rifampicin-resistant tuberculosis patients. Sci Rep. 2026 Mar 31;16(1):15255. doi: 10.1038/s41598-026-46217-2.
- Nyang'wa BT, Kloprogge F, Moore DAJ, Bustinduy A, Motta I, Berry C, Davies GR. Population pharmacokinetics and pharmacodynamics of investigational regimens' drugs in the TB-PRACTECAL clinical trial (the PRACTECAL-PKPD study): a prospective nested study protocol in a randomised controlled trial. BMJ Open. 2021 Sep 6;11(9):e047185. doi: 10.1136/bmjopen-2020-047185.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Clofazimine | Small molecule | 50 mg | Oral |
| Subject | Clofazimine | Small molecule | 100 mg | Oral |
| Subject | Linezolid | Other / unclassified | 300 mg | Oral |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | Pretomanid | Small molecule | 200 mg | Oral |