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Multidrug Resistant TuberculosisTB-TRUSTplusNCT04717908

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

A study testing Bedaquiline, Pyrazinamide and Linezolid in people with Multidrug Resistant Tuberculosis, run by Huashan Hospital at 15 sites 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

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB . Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multidrug Resistant Tuberculosis
What is being tested?
Bedaquiline, Pyrazinamide and Linezolid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
15 sitesChina
Study dates
20 Jan 2021to 22 Jun 2024
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to participate in trial treatment and follow-up and can give informed consent
  • 18-70 years old
  • Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin and isoniazide confirmed by GeneXpert
  • documented resistance to fluoroquinolones at screening
  • Can use bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide drugs concerning the availability and costs of essential medicines
  • Willing to carry out HIV testing.
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  • If the patient is a non-menopausal woman, agree to use or have used effective contraception during treatment.
  • Have an identifiable address and stay in the area during the study period.
  • Willing to follow the follow-up study procedure after the follow-up.

Who cannot join

  • Combined extrapulmonary tuberculosis;
  • HIV antibody positive and AIDS patients;
  • Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;
  • Known to be pregnant or breastfeeding;
  • Unable to attend or follow treatment or follow-up time;
  • Can not take oral medications;
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  • Patients with impaired liver function (hepatic encephalopathy, ascites; total bilirubin is more than 2 times higher than the upper limit of normal; ALT or AST is more than 5 times the upper limit of normal);
  • Blood muscle spasm is more than 1.5 times the upper limit of normal;
  • The investigator believes that there are any social or medical conditions that expose the subject to a safety hazard;
  • Simultaneously apply the drugs (glucocorticoids, interferons) that affect the efficacy of this study; and apply the following drugs contraindicated with the study drug, including non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors (phenethyl hydrazine, different Carbofurs et al), direct or indirect sympathomimetic drugs (such as pseudoephedrine), vasopressor drugs (such as adrenaline, norepinephrine), dopamine drugs (such as dopamine, dobutamine), 5 a serotonin reuptake inhibitor, a tricyclic antidepressant, a serotonin 5-HTI receptor antagonist (amitriptyline), meperidine or buspirone.
  • Being allergic or intolerant of any study drug;
  • Currently participating in another drug clinical trial;
  • QTc interval ≥ 500 milliseconds during screening;
  • Hemoglobin is less than 90g/L or platelet is less than 75*10^9/L;
  • Have epilepsy, severe depression, irritability or psychosis；
  • Alcohol abuse（drinking more than 64g of ethanol a day for male, 42g for female）.
  • Subjects receive more than 2 weeks of bedaquiline, linezolid, cycloserine, clofazimine or pyrazinamide 3 months prior to enrolment.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Baoshan People's Hospital

    Baoshan, Yunnan

  • Hunan Chest Hospital

    Changsha, Hunan

  • Guiyang Public Health Treatment Center

    Guizhou, Guizhou

  • Hangzhou Red Cross Hospital

    Hangzhou, Zhejiang

  • Huaihua first people's Hospital

    Huaihua, Hunan

  • Yunnan Provincial Infectious Disease Hospital

    Kunming, Yunnan

  • Jiangxi Chest Hospital

    Nanchang

  • Hwa Mei Hosptal,University of Chinese Academy of Sciences(Ningbo No.2 Hospital)

    Ningbo, Zhejiang

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The Third People's Hospital of Shenzhen City

    Shenzhen, Guangzhou

  • Taizhou Enze medical center Enze Hospital

    Taizhou, Zhejiang

  • Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC

    Ürümqi, Xinjiang

  • The Central Hospital of Wenzhou City

    Wenzhou, Zhejiang

  • Shanxi Provincial Tuberculosis Control Institute

    Xi’an, Shanxi

  • The Sixth People's Hospital of Zhengzhou

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T) (TB-TRUST)-PLUS

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .

Read the detailed description

The TB-TRUST-plus is a phaseIII, multicenter, open-label trial. The purpose of this study is to assess the feasibility of the ultra-short treatment regimen guided by PZA sensitivity among fluoroquinolone-resistant MDR-TB patients.A total of 200 participants with MDR-TB will be recruited and followed up until 84 weeks after the treatment initiation.

This regimen consists of two periods of 24-36 weeks. During the first 4-8 weeks(waiting for pyrazinamide drug sensitivity test), the regimen consists of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide. Then based on molecular PZA drug sensitivity results, patients will be in divided into 3 sub-groups: pyrazinamide-susceptible (PZA-S) patients , pyrazinamide-resistant (PZA-R) patients and pyrazinamide-unavailable (PZA-U)patients.

The Regimen for PZA-S patients, consisting of bedaquiline, linezolid, cycloserine and pyrazinamide, are given until the 24th week (prolonged to 28 or 32 weeks if no smear conversion by end of 16th and 20th week).

PZA-R sub-group regimen, consisting of bedaquiline, linezolid, cycloserine and clofazimine ,are given until 36th week (prolonged to 40 or 44 weeks if no smear conversion by end of 16th and 20th week) .

PZA-U sub-group continue the previous regimen, consisting of bedaquiline, linezolid, cycloserine , clofazimine and pyrazinamide ,until 36th week (prolonged to 40 or 44 weeks if no smear conversion by end of 16th and 20th week) .

The primary objective is to access the treatment success rate without relapse of the PZA sensitivity guided ultra short regimen.

The secondary objective is to access the median time to sputum culture conversion. Safety evaluations performed are the routine lab tests, blood glucose, vital signs, electrocardiograph (ECG), reporting of adverse events, peripheral neuropathy brief examining with the use of a Brief Peripheral Neuropathy rating scale(BPNS) and ophthalmologic examination, including assessment of visual acuity and color vision，physical examinations and chest CT. Adverse events will be monitored and promptly managed during the whole treatment course.

Being tested
Bedaquiline, Pyrazinamide, Linezolid, Cycloserine, Clofazimine
Keywords
Multidrug resistant tuberculosis, shorter treatment, all-oral regimen, PZA sensitivity
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.

  • BedaquilineDrug

    Also called BDQ

    400 mg once daily for 2 weeks then 200mg 3 times per week;

  • PyrazinamideDrug

    Also called PZA

    1500 mg daily

  • LinezolidDrug

    Also called LZD

    600 mg daily

  • CycloserineDrug

    Also called Cs

    ≤50kg 500 mg daily, >50kg 750mg daily;

  • ClofazimineDrug

    Also called CFZ

    100 mg daily;

Study groups in NCT04717908
Study groupRoleWhat they receive
PZA sensitivity guided all oral regimenExperimentalThis regimen consists of two periods of 24-36 weeks. During the first 4-8 weeks(waiting for pyrazinamide drug sensitivity test), the regimen consists of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide. Then based on molecular PZA drug sensitivity results, patients will be divided into three sub-groups. The regimen for PZA-S patients, consisting of bedaquiline, linezolid, cycloserine and pyrazinamide, are given until the 24th week (prolonged to 28 or 32 weeks if no smear conversion by end of 16th and 20th week). PZA-R sub-group regimen, consisting of bedaquiline, linezolid, cycloserine and clofazimine ,are given until 36th week (prolonged to 40 or 44 weeks if no smear conversion by end of 16th and 20th week) . PZA-U sub-group continue the previous regimen, consisting of bedaquiline, linezolid, cycloserine , clofazimine and pyrazinamide ,until 36th week (prolonged to 40 or 44 weeks if no smear conversion by end of 16th and 20th week) .
Receives: Drug: Bedaquiline; Drug: Pyrazinamide; Drug: Linezolid; Drug: Cycloserine; Drug: Clofazimine

What is being measured

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

  1. Treatment success rate

    To access the treatment success rate without relapse .Treatment outcomes will be classified into favourable outcome and unfavourable outcome.

    Measured: 84 weeks after the treatment initiation

Secondary outcomes (2)

  1. The median time to Sputum Culture Conversion

    time from treatment initiation to the first of two consecutive negative sputum cultures without an intervening positive culture in liquid media

    Measured: Time Frame: 12-36 weeks after treatment initiation

  2. The frequency of grade 3 or greater adverse events among patients

    to access the proportion of patients who experience grade 3 or greater adverse events (graded according to the Division of AIDS severity criteria for adverse events) during treatment or follow-up;

    Measured: 84 weeks after treatment initiation

Timeline

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

  1. First posted22 Jan 2021
  2. Study start20 Jan 2021
  3. Primary completion22 Jun 2024
  4. Study completion22 Jun 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04717908
Sponsor's protocol ID
KY1214
Acronym
TB-TRUSTplus
Status last verified
Nov 2024
First submitted
17 Jan 2021
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bedaquiline, Pyrazinamide and Linezolid in people with Multidrug Resistant Tuberculosis, run by Huashan Hospital at 15 sites 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 9 inclusion and 17 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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.

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?

Treatment success rate (time frame: 84 weeks after the treatment initiation). 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 NCT04717908.

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 12 Nov 2024.

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