Multidrug Resistant TuberculosisPhase 4TB-TRUSTNCT03867136
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)
A Phase 4 study testing PZA sensitivity guided ultra-short all Oral Regimen and Standardized Shorter Regimen in people with Multidrug Resistant Tuberculosis, run by Huashan Hospital at 13 sites in China.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36~44 weeks) in subjects with multidrug-resistant… 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?
- PZA sensitivity guided ultra-short all Oral Regimen and Standardized Shorter Regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 13 sitesChina
- Study dates
- 1 Jun 2020to 10 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Willing to participate in trial treatment and follow-up and can give informed consent 2.18-70 years old 3.Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by GeneXpert 4.Willing to carry out HIV testing. 5. If you are a non-menopausal woman, agree to use or have used effective contraception during treatment.
- 6. Have an identifiable address and stay in the area during the study period. 7.Willing to follow the follow-up study procedure after the follow-up.
Who cannot join
- Molecular drug resistance test for infected strains resistant to second-line injection;
- Molecular drug resistance assay for infected strains resistant to fluoroquinolone;
- 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;
Show all 18Show fewer
- Unable to attend or follow treatment or follow-up time;
- Can not take oral medications;
- 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；
- Alchol abuse（drinking more than 64g of ethanol a day for male, 42g for female）.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Hunan Chest Hospital
Changsha, Hunan
Guiyang Public Health Treatment Center
Guizhou, Guizhou
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, Zhejiang
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan
Jiangxi Chest Hospital
Nanchang
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
The Third People's Hospital of Shenzhen City
Shenzhen, Guangzhou
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
Xuzhou Infectious Disease Hospital
Xuzhou, Jiangsu
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan
About this study
Official title: Refining Multidrug Tuberculosis Treatment with the Ultra Short All Oral Regimen
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36~44 weeks) in subjects with multidrug-resistant tuberculosis (MDR-TB) compared to WHO standardized shorter regimen of 36-44 weeks.
Read the detailed description
The TB-TRUST is a phaseIII, multicenter, open-label, randomized controlled trial. The purpose of this study is to assess the feasibility of the ultra-short treatment regimen of all-oral anti-TB drugs among selected MDR-TB patients who are susceptible to fluoroquinolones.
A total of 354 participants with MDR-TB will be recruited and followed up until 84 weeks after randomization. During randomization, eligible patients will be assigned to in a 1:1 ratio to one of the following groups: The WHO standardized shorter regimen group and a PZA sensitivity guided ultra-short regimen group.
WHO standardized shorter regimen group consists of 36-44 weeks with two phases of treatment. The first is an intensive phase of 16 weeks (extended up a maximum of 20 or 24 weeks in case of lack of smear conversion at the end of 16 or 20 weeks), and included moxifloxacin, amikacin, prothionamide, pyrazinamide, high-dose isoniazid, ethambutol, and clofazimine. This is followed by a continuation phase of 20 weeks with the following agents: moxifloxacin, pyrazinamide, ethambutol, and clofazimine.
The PZA sensitivity guided ultra-short 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 levofloxacin, linezolid, cycloserine, pyrazinamide, and clofazimine. Then based on molecular PZA drug sensitivity results, patients will be in divided into two sub-groups: pyrazinamide-susceptible (PZA-S) patients and pyrazinamide-resistant (PZA-R) patients. The Regimen for PZA-S patients, consisting of levofloxacin, 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 levofloxacin, linezolid, cycloserine, and clofazimine given 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 compare the treatment success rate without relapse between the WHO standardized shorter regimen group and the PZA sensitivity guided ultra-short regimen group.
The secondary objective is to compare the median time to sputum culture conversion. Safety evaluations performed are the routine lab tests, blood glucose, hearing, 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.
- Conditions
- Multidrug Resistant Tuberculosis
- Being tested
- PZA sensitivity guided ultra-short all Oral Regimen, Standardized Shorter Regimen
- Keywords
- Multidrug resistant tuberculosis, shorter treatment, all-oral regimen
- 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.
PZA sensitivity guided ultra-short all Oral RegimenDrug
Pyrazinamide 1500 mg daily; Levofloxacin ≤50kg 500 mg daily, >50kg 750mg daily; Linezolid: 600 mg daily; Cycloserine ≤50kg 500 mg daily, >50kg 750mg daily; Clofazimine 100 mg daily; All treatment is taken daily;
Standardized Shorter RegimenDrug
Pyrazinamide 1500 mg daily;Levofloxacin 400 mg daily,; Prothionamide ≤50kg 500 mg daily, >50kg 750mg daily; Ethambutol: ≤50kg 750 mg daily, >50kg 1000mg daily; Clofazimine: 100 mg daily; Amikacin 600mg daily; High-dose isoniazid 600mg daily. All treatment is taken daily.
| Study group | Role | What they receive |
|---|---|---|
| PZA sensitivity guided ultra-short all Oral Regimen | Experimental | The PZA sensitivity guided ultra-short 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 levofloxacin, linezolid, cycloserine, pyrazinamide, and clofazimine. Then based on molecular PZA drug sensitivity results, patients will be in divided into two sub-groups: pyrazinamide-susceptible (PZA-S) patients and pyrazinamide-resistant (PZA-R) patients. The Regimen for PZA-S patients, consisting of levofloxacin, 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 levofloxacin, linezolid, cycloserine, and clofazimine given until 36th week (prolonged to 40 or 44 weeks if no smear conversion by end of 16th and 20th week) Receives: Drug: PZA sensitivity guided ultra-short all Oral Regimen |
| Standardized Shorter Regimen | Active comparator | WHO standardized shorter regimen group consists of 36-44 weeks with two phases of treatment. The first is an intensive phase of 16 weeks (extended up a maximum of 20 or 24 weeks in case of lack of smear conversion at the end of 16 or 20 weeks), and included moxifloxacin, amikacin, prothionamide, pyrazinamide, high-dose isoniazid, ethambutol and clofazimine. This is followed by a continuation phase of 20 weeks with the following agents: moxifloxacin, pyrazinamide, ethambutol and clofazimine. Receives: Drug: Standardized Shorter Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate of the ultra short regimen
To compare the treatment success rate without relapse between the PZA sensitivity guided all oral ultra short regimen group and the WHO standardized shorter regimen group. Treatment outcomes will be classified into favourable outcome and unfavourble outcome.
Measured: 84 weeks after randomization.
Secondary outcomes (2)
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 between the ultra short regimen group and the standardized short regimen group;
Measured: 12-36 weeks after treatment initiation
The frequency of grade 3 or greater adverse events among patients treated with the ultra short regimen
to compare 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, on the experimental regimen when compared to the control regimen;
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.
- First posted7 Mar 2019
- Study start1 Jun 2020
- Primary completion10 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multidrug Resistant TuberculosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867136
- Sponsor's protocol ID
- KY2018-331
- Acronym
- TB-TRUST
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weng T, Sun F, Li Y, Chen J, Chen X, Li R, Ge S, Zhao Y, Zhang W. Refining MDR-TB treatment regimens for ultra short therapy (TB-TRUST): study protocol for a randomized controlled trial. BMC Infect Dis. 2021 Feb 17;21(1):183. doi: 10.1186/s12879-021-05870-w.
PubMed 33596848
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining Multidrug Tuberculosis Treatment with the Ultra Short All Oral Regimen
- ClinicalTrials.gov ID
- NCT03867136
- Acronym / sponsor ID
- TB-TRUST / KY2018-331
- Conditions
- Multidrug Resistant Tuberculosis
- Keywords
- Multidrug resistant tuberculosis, shorter treatment, all-oral regimen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36~44 weeks) in subjects with multidrug-resistant tuberculosis (MDR-TB) compared to WHO standardized shorter regimen of 36-44 weeks.
Detailed description
The TB-TRUST is a phaseIII, multicenter, open-label, randomized controlled trial. The purpose of this study is to assess the feasibility of the ultra-short treatment regimen of all-oral anti-TB drugs among selected MDR-TB patients who are susceptible to fluoroquinolones.
A total of 354 participants with MDR-TB will be recruited and followed up until 84 weeks after randomization. During randomization, eligible patients will be assigned to in a 1:1 ratio to one of the following groups: The WHO standardized shorter regimen group and a PZA sensitivity guided ultra-short regimen group.
WHO standardized shorter regimen group consists of 36-44 weeks with two phases of treatment. The first is an intensive phase of 16 weeks (extended up a maximum of 20 or 24 weeks in case of lack of smear conversion at the end of 16 or 20 weeks), and included moxifloxacin, amikacin, prothionamide, pyrazinamide, high-dose isoniazid, ethambutol, and clofazimine. This is followed by a continuation phase of 20 weeks with the following agents: moxifloxacin, pyrazinamide, ethambutol, and clofazimine.
The PZA sensitivity guided ultra-short 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 levofloxacin, linezolid, cycloserine, pyrazinamide, and clofazimine. Then based on molecular PZA drug sensitivity results, patients will be in divided into two sub-groups: pyrazinamide-susceptible (PZA-S) patients and pyrazinamide-resistant (PZA-R) patients. The Regimen for PZA-S patients, consisting of levofloxacin, 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 levofloxacin, linezolid, cycloserine, and clofazimine given 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 compare the treatment success rate without relapse between the WHO standardized shorter regimen group and the PZA sensitivity guided ultra-short regimen group.
The secondary objective is to compare the median time to sputum culture conversion. Safety evaluations performed are the routine lab tests, blood glucose, hearing, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PZA sensitivity guided ultra-short all Oral Regimen | Experimental | Drug: PZA sensitivity guided ultra-short all Oral RegimenThe PZA sensitivity guided ultra-short 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 levofloxacin, linezolid, cycloserine, pyrazinamide, and clofazimine. Then based on molecular PZA drug sensitivity results, patients will be in divided into two sub-groups: pyrazinamide-susceptible (PZA-S) patients and pyrazinamide-resistant (PZA-R) patients. The Regimen for PZA-S patients, consisting of levofloxacin, 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 levofloxacin, linezolid, cycloserine, and clofazimine given until 36th week (prolonged to 40 or 44 weeks if no smear conversion by end of 16th and 20th week) |
| Standardized Shorter Regimen | Active comparator | Drug: Standardized Shorter RegimenWHO standardized shorter regimen group consists of 36-44 weeks with two phases of treatment. The first is an intensive phase of 16 weeks (extended up a maximum of 20 or 24 weeks in case of lack of smear conversion at the end of 16 or 20 weeks), and included moxifloxacin, amikacin, prothionamide, pyrazinamide, high-dose isoniazid, ethambutol and clofazimine. This is followed by a continuation phase of 20 weeks with the following agents: moxifloxacin, pyrazinamide, ethambutol and clofazimine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Willing to participate in trial treatment and follow-up and can give informed consent 2.18-70 years old 3.Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by GeneXpert 4.Willing to carry out HIV testing. 5. If you are a non-menopausal woman, agree to use or have used effective contraception during treatment.
- 6. Have an identifiable address and stay in the area during the study period. 7.Willing to follow the follow-up study procedure after the follow-up.
Key exclusion criteria (18 listed)
- Molecular drug resistance test for infected strains resistant to second-line injection;
- Molecular drug resistance assay for infected strains resistant to fluoroquinolone;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PZA sensitivity guided ultra-short all Oral RegimenPyrazinamide 1500 mg daily; Levofloxacin ≤50kg 500 mg daily, >50kg 750mg daily; Linezolid: 600 mg daily; Cycloserine ≤50kg 500 mg daily, >50kg 750mg daily; Clofazimine 100 mg daily; All treatment is taken daily; | Drug | PZA sensitivity guided ultra-short all Oral Regimen |
| Standardized Shorter RegimenPyrazinamide 1500 mg daily;Levofloxacin 400 mg daily,; Prothionamide ≤50kg 500 mg daily, >50kg 750mg daily; Ethambutol: ≤50kg 750 mg daily, >50kg 1000mg daily; Clofazimine: 100 mg daily; Amikacin 600mg daily; High-dose isoniazid 600mg daily. All treatment is taken daily. | Drug | Standardized Shorter Regimen |
Primary outcome
Treatment success rate of the ultra short regimen
Time frame: 84 weeks after randomization.
To compare the treatment success rate without relapse between the PZA sensitivity guided all oral ultra short regimen group and the WHO standardized shorter regimen group. Treatment outcomes will be classified into favourable outcome and unfavourble outcome.
2 secondary outcomes
The median time to Sputum Culture Conversion
Time frame: 12-36 weeks after treatment initiation
The frequency of grade 3 or greater adverse events among patients treated with the ultra short regimen
Time frame: 84 weeks after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 33596848Weng T, Sun F, Li Y, Chen J, Chen X, Li R, Ge S, Zhao Y, Zhang W. Refining MDR-TB treatment regimens for ultra short therapy (TB-TRUST): study protocol for a randomized controlled trial. BMC Infect Dis. 2021 Feb 17;21(1):183. doi: 10.1186/s12879-021-05870-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenhong Zhang, PhD principal investigator
Huashan Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PZA sensitivity guided ultra-short all Oral Regimen and Standardized Shorter Regimen in people with Multidrug Resistant Tuberculosis, run by Huashan Hospital at 13 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 2 inclusion and 18 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 13 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.
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?
Treatment success rate of the ultra short regimen (time frame: 84 weeks after randomization.). 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 NCT03867136, which also lists 1 linked publication.
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.