Who is sponsoring NCT03561753?

NCT03561753 is sponsored by Shanghai Pulmonary Hospital, Shanghai, China.

What drugs are being tested in NCT03561753?

Interventions in NCT03561753: Group A (the standard 2HRZE/4HR regimen）, Group B (New short course PRS regimen, 4EZ(high dose)PtoCfz).

What condition does NCT03561753 study?

NCT03561753 studies Pulmonary Tuberculosis TB in Sputum: (+) Microscopy.

Is NCT03561753 still recruiting?

NCT03561753 is currently completed. Last updated 9 November 2020.

Last reviewed 2020-11-09 · How we verify

NCT03561753

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

Pilot Clinical Trial of PRS TB Regimen I - Phase II

Completed Phase 4 Last updated 9 November 2020

What this trial tests

Phase 4 trial testing Group A (the standard 2HRZE/4HR regimen） in Pulmonary Tuberculosis TB in Sputum: (+) Microscopy in 97 participants. Completed in 31 January 2020.

Timeline

1 December 2017

Primary endpoint
31 December 2019

31 January 2020

Quick facts

Lead sponsor	Shanghai Pulmonary Hospital, Shanghai, China
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	97
Start date	1 December 2017
Primary completion	31 December 2019
Estimated completion	31 January 2020
Sites	4 locations across China

Drugs / interventions tested

Group A (the standard 2HRZE/4HR regimen） — full drug profile →
Group B (New short course PRS regimen, 4EZ(high dose)PtoCfz) — full drug profile →

Conditions studied

Pulmonary Tuberculosis TB in Sputum: (+) Microscopy — all drugs for Pulmonary Tuberculosis TB in Sputum: (+) Microscopy →

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Who can join

Adults 18 to 65, any sex, with Pulmonary Tuberculosis TB in Sputum: (+) Microscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tuberculosis is the current leading cause of death due to an identifiable infectious agent worldwide. The current standard regimen for tuberculosis requires a patient to take drug combination (isoniazid, rifampicin, ethambutol, and pyrazinamide) for six to eight month periods. The purpose of this study is to compare tuberculosis treatment therapy between the current standard regimen and PRS derived combinatorial regimen. PRS derived regimen may potentially allow for a shorter course of treatment, which may reduce problems associated with adherence, toxicity, and development of drug resistance.

Publications & conference data

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

Shortened tuberculosis treatment regimens: what is new?
Silva DR, Mello FCQ, Migliori GB. · · 2020 · cited 18× · PMID 32215450 · DOI 10.36416/1806-3756/e20200009
Efficacy and safety of an innovative short-course regimen containing clofazimine for treatment of drug-susceptible tuberculosis: a clinical trial.
Zheng X, Gui X, Yao L, Ma J, et al · · 2023 · cited 6× · PMID 36872899 · DOI 10.1080/22221751.2023.2187247
A 3-month clofazimine-rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial.
Metcalfe JZ, Weir IR, Scarsi KK, Mendoza-Ticona A, et al · · 2026 · cited 1× · PMID 40915311 · DOI 10.1016/s1473-3099(25)00436-0
Association of T-Cell Profiles With Disease Severity, Drug-Induced Liver Injury, and Treatment Completion in Tuberculosis.
He Y, Zheng X, Dang Z, Hao X, et al · · 2025 · cited 1× · PMID 40746087 · DOI 10.1111/crj.70114

Verify or expand the search:

Other Shanghai Pulmonary Hospital, Shanghai, China trials

Trials by the same sponsor.

NCT07469488 — A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-M · Phase 4 · not yet recruiting
NCT07494591 — TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery · NA · not yet recruiting
NCT07517640 — Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial · Phase 2 · not yet recruiting
NCT07393438 — Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS) · Phase 2 · not yet recruiting
NCT07375979 — A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-cente · not yet recruiting

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 NCT03561753 (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 Shanghai Pulmonary Hospital, Shanghai, China
Last refreshed: 9 November 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/NCT03561753.

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