NCT04081077 (PRACTECAL-PKPD) is a Phase 2, PHASE3 clinical trial of Bedaquiline in Multi-drug Resistant Tuberculosis, sponsored by Medecins Sans Frontieres, Netherlands.

Who is sponsoring NCT04081077?

NCT04081077 is sponsored by Medecins Sans Frontieres, Netherlands.

What drugs are being tested in NCT04081077?

Interventions in NCT04081077: Bedaquiline, Pretomanid, Moxifloxacin, Linezolid, Clofazimine.

What condition does NCT04081077 study?

NCT04081077 studies Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis.

Is NCT04081077 still recruiting?

NCT04081077 is currently status unknown. Last updated 14 May 2021.

Last reviewed 2021-05-14 · How we verify

NCT04081077: PRACTECAL-PKPD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PRACTECAL-PKPD Sub Study

Status unknown Phase 2, PHASE3 Last updated 14 May 2021

What this trial tests

Phase 2, PHASE3 trial testing Bedaquiline in Multi-drug Resistant Tuberculosis in 240 participants. Status unknown.

Timeline

6 August 2019

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	Medecins Sans Frontieres, Netherlands
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	6 August 2019
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	5 locations across South Africa, Belarus

Drugs / interventions tested

Bedaquiline (bedaquiline) — full drug profile →
Pretomanid
Moxifloxacin (moxifloxacin) — full drug profile →
Linezolid — full drug profile →
Clofazimine (clofazimine) — full drug profile →

Conditions studied

Multi-drug Resistant Tuberculosis — all drugs for Multi-drug Resistant Tuberculosis →
Extensively Drug-Resistant Tuberculosis — all drugs for Extensively Drug-Resistant Tuberculosis →
Pulmonary Tuberculosis — all drugs for Pulmonary Tuberculosis →

Sponsor

Medecins Sans Frontieres, Netherlands — full company profile →

Who can join

18 and older, any sex, with Multi-drug Resistant Tuberculosis or Extensively Drug-Resistant Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

Advances of new drugs bedaquiline and delamanid in the treatment of multi-drug resistant tuberculosis in children.
Zhu H, Zhou X, Zhuang Z, Li L, et al · · 2023 · cited 11× · PMID 37384221 · DOI 10.3389/fcimb.2023.1183597
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.
Nyang'wa BT, Kloprogge F, Moore DAJ, Bustinduy A, et al · · 2021 · cited 9× · PMID 34489274 · DOI 10.1136/bmjopen-2020-047185
Population pharmacokinetics and target attainment of pretomanid in rifampicin-resistant tuberculosis patients.
Nyang'wa BT, Motta I, Moodliar R, Solodovnikova V, et al · · 2026 · PMID 41917253 · DOI 10.1038/s41598-026-46217-2

Verify or expand the search:

Other trials of Bedaquiline

Trials testing the same drug.

NCT06192160 — Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2 · recruiting
NCT06081361 — Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezol · Phase 3 · active not recruiting
NCT05766267 — Short-course Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2, PHASE3 · active not recruiting
NCT05824871 — A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients · Phase 3 · recruiting
NCT05382312 — Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established A · Phase 2 · completed

Other Medecins Sans Frontieres, Netherlands trials

Trials by the same sponsor.

NCT04268524 — Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Paki · Phase 3 · recruiting
NCT04207112 — Economic Evaluation of New MDR TB Regimens · Phase 2, PHASE3 · completed
NCT03942354 — Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial · completed
NCT03208543 — Effectiveness, Safety and Feasibility of HECT-CL, in Quetta, Pakistan · Phase 3 · terminated
NCT03311607 — Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04081077 (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 Medecins Sans Frontieres, Netherlands
Last refreshed: 14 May 2021

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/NCT04081077.

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