A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB

NCT05278988 | Completed Phase 4

• 1 other identifier: K21-024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.

Conditions

MDR-TB

Keywords

MDR-TB; Delamanid; bedaquiline

Outcome Measures

Primary Outcomes (1)

• patient cure rate

  Assessment of cure rate : 1. Cure. 2. Treatment completion. 3. Treatment failure. 4. Death. 5. Loss. 6. Inconclusive. 7. Treatment success.

  Through study completion, an average of 18 months

Secondary Outcomes (6)

• Early bactericidal activity (EBA)

  treatment initiation (Day 0; D0) and on Day 2 (D2), Day 7 (D7), and Day 14 (D14) after the start of treatment

• Time to culture positivity

  Through study completion, an average of 18 months

• Sputum conversion rate

  Through study completion, an average of 18 months

• Radiology changes

  Through study completion, an average of 18 months

• Relapse rate one and two years after treatment completion.

  At 3, 6, 12, 18, and 24 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Treatment according to WHO MDR-TB treatment guidelines (2019).

Drug: MDR-TB Treatment Regimen(WHO)

Group B(PRS Regimen V)

EXPERIMENTAL

bedaquiline, delamanid, clofazimine, pyrazinamide

Drug: PRS Regimen V

Interventions

PRS Regimen V DRUG

PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)

Group B(PRS Regimen V)

MDR-TB Treatment Regimen(WHO) DRUG

Treatment according to WHO MDR-TB treatment guidelines (2019)

Also known as: WHO Regimen

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated newly diagnosed patients with rifampicin resistant (RR) or multidrug resistant (MDR)-TB.
• Newly treated patients: at least twice confirmed by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB; Retreated patients: confirmed once by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB.
• Age between 18 and 65.
• No abnormality on EKG.
• Able to understand and sign informed consent form.

You may not qualify if:

• Presence of extrapulmonary TB (including tuberculous pleurisy);
• History of allergic reaction to any of the drugs used in the study;
• Presence of any of the following conditions that can lead to prolonged QT:
• During screening process, ECG shows QT or QTc interval ≥ 450 ms (permit one non-prescheduled retest within the screening period to re-evaluate the testees' qualification);
• Pathological Q waves (any Q wave duration of \> 40 ms or depth \> 0.4-0.5 mV);
• Evidence of ventricular pre-excitation (such as Wolff-Parkinson-White Syndrome);
• EKG shows evidence of complete or clinically significant incomplete left or right bundle branch block;
• Evidence of 2nd or 3rd degree heart block;
• Intraventricular conduction delay, QRS durations \> 120 ms;
• Slow heart rate, defined as sinus heart rate \< 50 bpm;
• Having personal or family history of long QT syndrome;
• Having heart disease, symptomatic or asymptomatic arrhythmia, excluding sinus arrhythmia;
• Fainting (i.e., cardiogenic fainting, not including vasovagal syncope or seizure)
• Having risk factors for Torsade de pointes ventricular tachycardia (e.g. heart failure, hypokalemia, hypomagnesemia)
• Pregnancy or liver, kidney, metabolic, autoimmunity, neurological, psychological or endocrine disease, blood system disease, malignant cancer, long-term users of immunosuppressant drugs.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Shanghai Public Health Clinical Center: collaborator
• No.85 Hospital, Changning, Shanghai, China: collaborator
• Ganzhou Fifth People's Hospital, China: collaborator
• Weifang Second People's Hospital, China: collaborator
• Anhui Chest Hospital: collaborator
• Fourth Taiyuan People's Hospital, China: collaborator
• Shanghai Pudong New Area Pulmonary Hospital, China: collaborator
• Huashan Hospital: collaborator
• Zhengzhou Sixth People's Hospital, China: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

Location

Related Publications (3)

• Aung KJ, Van Deun A, Declercq E, Sarker MR, Das PK, Hossain MA, Rieder HL. Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis. 2014 Oct;18(10):1180-7. doi: 10.5588/ijtld.14.0100.

  PMID: 25216831 BACKGROUND

• Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, Rieder HL. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010 Sep 1;182(5):684-92. doi: 10.1164/rccm.201001-0077OC. Epub 2010 May 4.

  PMID: 20442432 BACKGROUND

• Silva A, Lee BY, Clemens DL, Kee T, Ding X, Ho CM, Horwitz MA. Output-driven feedback system control platform optimizes combinatorial therapy of tuberculosis using a macrophage cell culture model. Proc Natl Acad Sci U S A. 2016 Apr 12;113(15):E2172-9. doi: 10.1073/pnas.1600812113. Epub 2016 Mar 28.

  PMID: 27035987 BACKGROUND

Related Links

• WHO consolidated guidelines on drug-resistant tuberculosis treatment

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sha wei

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Tuberculosis Department,Shanghai Pulmonary Hospital, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 15, 2022
• Study Start: April 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)