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AzTrials

MDR-TBPhase 4NCT05278988

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

A Phase 4 study testing PRS Regimen V and MDR-TB Treatment Regimen(WHO) in people with MDR-TB, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
MDR-TB
What is being tested?
PRS Regimen V and MDR-TB Treatment Regimen(WHO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Apr 2021to 30 Oct 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 19Show fewer
  • 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.
  • Alcoholism
  • Any patients, based on the judgement of the study medical researchers who are not suitable to participate in the trial or unlikely to complete the trial.
  • Participating in another clinical trial at the same time.
  • History of non-compliance in other clinical trials.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai

Other trials in China

About this study

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.

Read the detailed description

Shortening the course of treatment based on effective therapy can significantly improve patient compliance and reduce the public health burden.Research on optimal drug combination regimens to further shorten the duration and improve the efficacy of multidrug-resistant tuberculosis treatment is an important research direction.The PRS (parabolic response surface, FSC.II) system is an enhanced use of FSC to better identify and optimize optimal drug combinations.In preliminary studies, it was determined that PRS Regimens V （bedaquiline, delamanid, clofazimine, pyrazinamide）was superior to other regimens and would be a promising combination for XDR-TB because it does not contain fluoroquinolones or aminoglycosides. Preliminary trials have demonstrated that this regimen (PRS Regimens IV) can significantly reduce the duration of treatment required for MDR-TB and achieve a relapse-free cure.

Therefore, the investigators conducted an exploratory, prospective, randomized, positive-controlled, open, multicenter clinical study of this new regimen to observe the efficacy, safety, and recent relapse rate of the new regimen in the treatment of multidrug-resistant tuberculosis.

Conditions
MDR-TB
Being tested
PRS Regimen V, MDR-TB Treatment Regimen(WHO)
Keywords
MDR-TB, Delamanid, bedaquiline
Medical subject headings
Tuberculosis, Multidrug-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRS Regimen VDrug

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

  • MDR-TB Treatment Regimen(WHO)Drug

    Also called WHO Regimen

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

Study groups in NCT05278988
Study groupRoleWhat they receive
Group AActive comparatorTreatment according to WHO MDR-TB treatment guidelines (2019).
Receives: Drug: MDR-TB Treatment Regimen(WHO)
Group B(PRS Regimen V)Experimentalbedaquiline, delamanid, clofazimine, pyrazinamide
Receives: Drug: PRS Regimen V

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, an average of 18 months

Secondary outcomes (6)

  1. Early bactericidal activity (EBA)

    Collect patient sputum between 16:00 to 8:00 the next morning before taking drugs prior to treatment initiation (Day 0; D0) and on Day 2 (D2), Day 7 (D7), and Day 14 (D14) after the start of treatment

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

  2. Time to culture positivity

    culture using MGIT 960 and observe the time to detection of positive growth.

    Measured: Through study completion, an average of 18 months

  3. Sputum conversion rate

    ompare patient sputum conversion rate between the two groups at one month and two months.

    Measured: Through study completion, an average of 18 months

  4. Radiology changes

    "Significant absorption" is defined as lesion absorption ≥ ½. "Absorption" is defined as lesion absorption ≤ ½. "No change" if the original lesion has no clear change. "Worsened" if the original lesion is enlarged or has spread. "Closure" if the original cavity is enclosed or enclosed by blockage. "Shrinkage" if diameter of the original cavity decreased by ≥1/2. "No change" if diameter of the original cavity decreases by <1/2. "Enlarged" if diameter of the original cavity increases by >1/2.

    Measured: Through study completion, an average of 18 months

  5. Relapse rate one and two years after treatment completion.

    follow up at 3, 6, 12, 18, and 24 months after treatment completion

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

  6. Time to Cure by Primary Endpoint criteria

    Time to Cure by Primary Endpoint criteria

    Measured: 6-9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start1 Apr 2021
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05278988
Sponsor's protocol ID
K21-024
Status last verified
Nov 2024
First submitted
24 Feb 2022
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25216831

  • 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.

    PubMed 20442432

  • 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.

    PubMed 27035987

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PRS Regimen V and MDR-TB Treatment Regimen(WHO) in people with MDR-TB, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

patient cure rate (time frame: Through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05278988, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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