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Multi-drug Resistant TuberculosisPhase 4NCT03830671

The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB

A Phase 4 study testing 18-month regimen containing 6 anti-TB drugs in people with Multi-drug Resistant Tuberculosis, run by Beijing Chest Hospital at 20 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

WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to deliver effective treatment and care. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multi-drug Resistant Tuberculosis
What is being tested?
18-month regimen containing 6 anti-TB drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
20 sitesChina
Study dates
8 Mar 2019to 8 Jun 2022
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

  • Is willing and able to give informed consent to participate in the trial treatment and follow-up.
  • Is aged between 18 years and 70 years.
  • Has a positive sputum culture result or a positive GeneXpert result.
  • Has evidence of RR-TB or MDR-TB either by GeneXpert or culture-based drug susceptibility testing (DST).
  • Non pre-XDR-TB or XDR-TB.
  • Is willing to use effective contraception of women at childbearing age.
  • Has had a chest X-ray that is compatible with a diagnosis of pulmonary TB.

Who cannot join

  • pre-XDR-TB or XDR-TB.
  • Has a known allergy to any drug of the regimen.
  • Is currently taking or took part in another trial less than three months before the study initiation .
  • Is HIV positive.
  • Has abnormal ECG with QT prolongation over 430ms of men while 450 of women.
  • Is critically ill, and in the judgment of the investigator, unlikely to take part in the study.Or has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe.
Show all 10Show fewer
  • Is known to be pregnant or breast-feeding.
  • Has severe cardiovascular diseases, such as heart failure, hypertension (poor blood pressure control), arrhythmia or post-infarction status.
  • Has severe concomitant severe disease such as respiratory failure or cardiac insufficiency or liver and kidney injury with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2.5 times the upper limit of normal or with serum creatinine(Cr)more than 1.3 times the upper limit of normal.
  • Has Karnofsky score less than 50%

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Beijing Chest Hospital

    Beijing

  • The 8th Medical Center of Chinese Pla General Hospital

    Beijing

  • Changchun Infectious Disease Hospital

    Changchun

  • Hunan Institute For Tuberculosis Control

    Changsha

  • Public Health Clinical Center of Chengdu

    Chengdu

  • Shenzhen Third Peple's Hospital

    Guangzhou

  • Guangzhou Chest Hospital

    Guanzhou

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang

  • Infectious Disease Prevention Hospital in Heilongjiang Province

    Harbin

  • Anhui Chest Hospital

    Hefei

  • The Fourth People's Hospital of Inner Mongolia Autonomous region

    Hohhot

  • Shandong Provincial Chest Hospital

    Jinan

  • Shanghai Pulmonary Hospital

    Shanghai

  • Shenyang Chest Hospital

    Shenyang

  • Tianjin Haihe Hospital

    Tianjin

  • Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC

    Ürümqi

  • The Tuberculosis Prevention and Treatment Hospital of Shanxi Province

    Xi'an

  • Xi'an Chest Hospital

    Xi'an

  • The Fourth People's Hospital of Ningxia Autonomous Region

    Yinchuan

  • The Infectious Disease Hospital of Wangkai Zaozhuang

    Zaozhuang

Other trials in China

About this study

Official title: The Effect of New MDR-TB Regimen With 18 Month Duration Containing 6 Anti-tuberculosis Drugs

WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to deliver effective treatment and care. According to the 2018 WHO TB Report, the overall treatment success rate of MDR-TB is 55% while much lower in China at just only 41% with the 24-month regimen. In order to further verify the safety and efficiency of optimizing shorter 18-month regimen containing 6 anti-TB drugs with MDR-TB patients,500 more patients will be enrolled and observed.

Read the detailed description
  1. Design: the study is a multi-center,open, single arm trial.
  2. Population:patients with sputum culture positive and confirmed as MDR-TB via drug resistance of isoniazid(H),rifampicin(R),ethambutol(E)and pyrazinamide or patients with GeneXpert confirmed RR-TB.
  3. Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of the 3 drugs in the regimen is explained as follows: PZA-pyrazinamide，Am-Amikacin，Mfx-moxifloxacin）and the total duration of the regimen is 18 months.
  4. Primary and secondary outcome measures: The primary outcome measures include 1.the treatment success rate.2. Death rate. The secondary outcome measures include 1.sputum conversion rate at the end of month 2, month 3,intensive phase of 6 months and treatment completion of all enrolled patients.2.Frequency of adverse drug reaction occurring during treatment.3.Radiological manifestation change of TB lesion or cavity during treatment.
  5. Sample size: 500 eligible patients will be enrolled.
Being tested
18-month regimen containing 6 anti-TB drugs
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.

  • 18-month regimen containing 6 anti-TB drugsDrug

    Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of each drug in the regimen is explained as follows: PZA-pyrazinamide，Am-Amikacin，Mfx-moxifloxacin）and the total duration of the regimen is 18 months

Study groups in NCT03830671
Study groupRoleWhat they receive
investigational armExperimentalthe arm was given investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of each drug in the regimen is explained as follows: PZA-pyrazinamide，Am-Amikacin，Mfx-moxifloxacin）and the total duration of the regimen is 18 months.
Receives: Drug: 18-month regimen containing 6 anti-TB drugs

What is being measured

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

  1. the treatment success rate

    Measured: at the end of treatment completion of all enrolled patients,an average of 18 months after the last patient enrolled

  2. death rate

    Measured: at the end of treatment completion of all enrolled patients, an average of 18 months after the last patient enrolled

Secondary outcomes (3)

  1. sputum conversion rate at the end of month 2, month 3,intensive phase and treatment completion.

    Measured: at the end of month 2, month 3,intensive phase of 6 months since treatment initiation and treatment completion of all enrolled patients, an average of 18 months after the last enrolled patient.

  2. Frequency of adverse drug reaction occurring during treatment.

    Measured: at the end of treatment completion of all enrolled patients, an average of 18 months after the last enrolled patient.

  3. Radiological manifestation change of TB lesion or cavity at the end of month 2, month 3,intensive phase and treatment completion.

    proportion of lung field the lesion accumulated taken up at different time points with the comparison to that at baseline. The number and size of cavities at different time points with comparison to that at baseline.

    Measured: at the end of month 2, month 3,intensive phase of 6 months since treatment initiation and treatment completion of all enrolled patients, an average of 18 months after the last enrolled patient.

Timeline

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

  1. First posted5 Feb 2019
  2. Study start8 Mar 2019
  3. Primary completion8 Jun 2022
  4. Study completion8 Jun 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03830671
Sponsor's protocol ID
2018ZX10722301-001
Status last verified
Oct 2022
First submitted
31 Jan 2019
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 18-month regimen containing 6 anti-TB drugs in people with Multi-drug Resistant Tuberculosis, run by Beijing Chest Hospital at 20 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 7 inclusion and 10 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

the treatment success rate (time frame: at the end of treatment completion of all enrolled patients,an average of 18 months after the last patient enrolled). The study lists 2 primary outcomes in all. 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 NCT03830671.

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 Oct 2022.

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