AzTrials
AzTrials

Tuberculosis, PulmonaryPhase 4NCT02901288

Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis

A Phase 4 study testing Isoniazid, Rifampicin and Pyrazinamide in people with Tuberculosis, Pulmonary, run by Beijing Chest Hospital at 35 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World Health Organization recommended standard 6-month regimen. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tuberculosis, Pulmonary
What is being tested?
Isoniazid, Rifampicin and Pyrazinamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,900 participants
Where
35 sitesChina
Study dates
Aug 2016to Dec 2018
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

  • Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate).
  • Is aged 18-65 years.
  • Has twice positive acid-fast bacilli(AFB) sputum smear or positive sputum culture result, along with chest x-ray imaging consistent with active pulmonary tuberculosis.
  • Newly diagnosed cases receiving anti-TB treatment for less than one month
  • Urine Human Chorionic Gonadotropin(U-HCG) negative and must agree to use effective contraception during the trial period.
  • Has Alanine aminotransferase（ALT）and Total bilirubin（TBil） less than 2 times the upper limit of normal ; has Creatinine clearance rate （CrCI） more than 30ml/min; has Hemoglobin more than 7.0g/dL; has Platelet（PLT）more than 50 x10^9/L before study entry.

Who cannot join

  • Concomitant severe cardiovascular, liver, kidney, nervous system, hematopoietic system and other diseases, or concomitant neoplastic diseases. Or extensive lesion with respiratory insufficiency.
  • Uncontrolled diabetes mellitus.
  • Concomitant mental disorders.
  • Is HIV positive.
  • Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
  • Is known to be pregnant or breast-feeding.
Show all 11Show fewer
  • Is unable or unwilling to comply with the treatment, assessment, or follow-up schedule.
  • Is taking any medications contraindicated with the medicines in any trial regimen of the study.
  • Has a known allergy to any drug of treatment regimens.
  • Is currently taking part in another trial.
  • Has a QTc interval more than 480ms.

Trial locations and contacts

35 sites in 1 country.

Shenjie Tang, MD contact

tangsj1106@sina.com

35 sites in 1 country

China35 sites, 35 recruiting

  • Beijing Research Institute for Tuberculosis Control

    Beijing, Beijing Municipality, 100000

    xiaoxin he, 13718716778, hexiaoxinbj@126.com

    Recruiting

  • Beijing Chest Hospital,Capital Meical University

    Beijing, Beijing Municipality, 101149

    mengqiu Gao, 13611009420, gaomqwdm@aliyun.com

    Recruiting

  • Changchun Infectious Disease Hospital

    Changchun, Jilin, 130000

    jian Zhang, 13944141394, jianzhang20080808@aliyun.com

    Recruiting

  • Hunan Institute For Tuberculosis Control

    Changsha, Hunan, 410000

    yisheng Huang, 139-7516-9056, 1756325210@qq.com

    Recruiting

  • Public Health Clinical Center of Chengdu

    Chengdu, Sichuan, 610061

    guihui Wu, 13056668540, wghwgh2584@sina.com

    Recruiting

  • Chongqing Infectious Disease Medical Center

    Chongqing, Chongqing Municipality, 500106

    xiaofeng yan, 15922784944, 2429918342@qq.com

    Recruiting

  • Centre for Tuberculosis Control of Guangdong Province

    Guangzhou, Guangdong, 510000

    huizhong wu, 13798123288, 1627639699@qq.com

    Recruiting

  • Heilongjiang Province center for tuberculosis Control and Prevention

    Haerbin, Heilongjiang, 150000

    yanling Yu, 18645092935, hljlfb@163.com

    Recruiting

  • Harbin Chest Hospital

    Harbin, Heilongjiang, 150000

    lianzhi Wang, 13836176215, 1186433640@qq.com

    Recruiting

  • Infectious Disease Prevention Hospital in Heilongjiang Province

    Harbin, Heilongjiang, 150000

    jintao tang, 13766987870, liuyuqin_ssy@163.com

    Recruiting

  • The Infectious Hospital of Hebi

    Hebi, Henan, 458000

    lin zhang, 13783022531, 923657539@qq.com

    Recruiting

  • Anhui Chest Hospital

    Hefei, Anhui, 230000

    gang Liu, 13955168886, liu802208@163.com

    Recruiting

  • Tuberculosis Hospital in Jilin Province

    Jilin City, Jilin, 132000

    peng Sun, 13630567999, 763515780@qq.com

    Recruiting

  • Kaifeng Pulmonary Disease Hospital

    Kaifeng, Henan, 475000

    zhenya Ma, 13937886599, 861852536@qq.com

    Recruiting

  • The Third People's Hospital of Kunming City

    Kunming, Yunnan, 650041

    mingwu Li, 13888428168, wanrong123@163.com

    Recruiting

  • Pulmonary Hospital of Lanzhou

    Lanzhou, Gansu, 730000

    Jianjun Ma, 13919319518, lfmjj50@163.com

    Recruiting

  • Guangxi Center for Disease Prevention and Control

    Nanning, Guangxi, 530000

    shuhai Huang, 13877102829, shuhaihuang@126.com

    Recruiting

  • The Sixth People's Hospital of Nantong

    Nantong, Jiangsu, 226000

    ying Yuan, 13906293240, 515020737@qq.com

    Recruiting

  • Sixth People's Hospital of Nanyang City

    Nanyang, Henan, 473000

    shulin zhai, 13598220698, 106273621@qq.com

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200000

    lin Fan, 13918569516, fanlinsj@163.com

    Recruiting

  • China Shenyang Chest Hospital

    Shenyang, Jilin, 110000

    juan Zhang, 18840000208, tb10ywk@163.com

    Recruiting

  • HeBei Province Center for Disease Prevention and Control

    Shijiazhuang, Hebei, 050000

    haifeng chen, 13503311328, chenhaifeng2071@163.com

    Recruiting

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu, 215000

    meiying Wu, 13906133614, wu-my@126.com

    Recruiting

  • Taiyuan Fourth People's Hospital

    Taiyuan, Shanxi, 030000

    Ling Gao, 13613456715, 398799102@qq.com

    Recruiting

  • The Infectious Disease Hospital of Wangkai Zaozhuang

    Tengzhou, Shandong, 277500

    yanyou chu, 13626329377, lw978@163.com

    Recruiting

  • Tianjin Haihe Hospital

    Tianjin, Tianjin Municipality, 300000

    zaoxian Mei, 18920180092, 1796135865@qq.com

    Recruiting

  • Tianjin centers for Disease Control and Prevention

    Tianjin, Tianjin Municipality, 300041

    yanyong fu, 13312129913, fuyanyong@sina.com

    Recruiting

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

    Ürümqi, Xinjiang, 830001

    ertai a, 18999853468, xkyyaertai@126.com

    Recruiting

  • Wuhan medical treatment center

    Wuhan, Hubei, 430000

    ming wei, 13667221289, 1508257434@qq.com

    Recruiting

  • Wuhan Institute For Tuberculosis Control

    Wuhan, Hubei, 430030

    peng peng, 13397192727, pengpengwg@126.com

    Recruiting

  • The Tuberculosis Prevention and Treatment Hospital of Shanxi Province

    Xi’an, Shanxi, 710100

    qianhong wu, 13891927416, 2271515862@qq.com

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xianxiang, Henan, 453100

    xiuqin Cui, 15837315900, cuixiuqin4402973@126.com

    Recruiting

  • The 4th People's Hospital of Qinghai Province

    Xining, Qinghai, 810000

    wenyuan Zhang, 13519707409, 13519707409@163.com

    Recruiting

  • The Fourth People's Hospital of Ningxia Autonomous Region

    Yinchuan, Ningxia, 750000

    guoren Ma, 18909508998, zhyl114@qq.com

    Recruiting

  • The Third People's Hospital of Zenjiang

    Zhenjiang, Jiangsu, 212005

    hongqiu Pan, 13951286001, 1622728518@qq.com

    Recruiting

Other trials in China

About this study

Official title: Shortened Regimens for First Diagnosed Smear Positive Drug Susceptible Pulmonary Tuberculosis: a Randomised Controlled Non-inferiority Trial

The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World Health Organization recommended standard 6-month regimen.

Read the detailed description
  1. Design: The study is a multi-center, randomized,controlled non-inferiority trial.
  2. Population: patients with newly diagnosed drug-susceptible pulmonary TB who fulfill the inclusion and exclusion criteria.
  3. Investigational regimens: Experimental group 1 regimen consists of levofloxacin, isoniazid , rifampicin,ethambutol and pyrazinamide for 4.5 months. Experimental group 2 regimen consists of isoniazid, rifampicin, ethambutol and pyrazinamide for 4.5 months. The control group is WHO recommended regimen conmposed of isoniazid , rifampicin, ethambutol and pyrazinamide for 2 months, followed by isoniazid , rifampicin for 4 months. Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg(less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily), levofloxacin 600mg(less than 50kg,given once daily) or 800mg(more than 50kg,once daily)..
  4. Trial objectives: to evaluate that shortened regimens is not inferior to standard treatment in terms of efficacy and safety for new smear positive pulmonary TB patients.
  5. Primary and Secondary outcome measures: The primary efficacy outcome measures include (a)the percentage of participants with TB recurrence/relapse by 24 months after the end of treatment;(b) percentage of participants with treatment failure at either 4.5 months or 6 months after randomization. (a) Time to sputum smear or culture conversion within intensive phase.(b) Sputum smear conversion proportion at the treatment completion. (c) Number of adverse drug reaction occurring during treatment or follow-up period. (d) Radiological manifestation change of TB lesion or cavity.(e) Patients adherence rate.
  6. Sample Size: Approximately 3900 participants will be enrolled and randomized with 1:1:1 ratio into either Experimental group1, Experimental group2 or control group.
  7. Blinding: The study is an open-label study.
  8. Assessment and follow-up:

All patients will be followed by to 2 years after completion of treatment.

Being tested
Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, Levofloxacin
Keywords
pulmonary tuberculosis, shortened regimen, clinical trial
Medical subject headings
Tuberculosis, Pulmonary

What participants receive

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

  • IsoniazidDrug

    Isoniazid is a widely used anti-tuberculosis medication. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique components of mycobacterial cell wall.

  • RifampicinDrug

    Rifampicin is a widely used anti-tuberculosis medication.

  • PyrazinamideDrug

    Pyrazinamide is a commonly used medication for tuberculosis, with bactericidal effect against intracellular mycobacterium tuberculosis.

  • EthambutolDrug

    Ethambutol is a widely used medicine in anti-TB regimens with bacteriostatic effect against M. tb.

  • LevofloxacinDrug

    Also called Cravit

    Levofloxacin is a commonly used antimicrobial for TB and other infections, which acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.

Study groups in NCT02901288
Study groupRoleWhat they receive
experimental group1ExperimentalThe experimental group1 all oral regimen is consisted of isoniazid,rifampin, pyrazinamide, ethambutol and levofloxacin for 4.5 months. Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg((less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily), levofloxacin 600mg(less than 50kg,given once daily) or 800mg(more than 50kg,once daily).
Receives: Drug: Isoniazid; Drug: Rifampicin; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Levofloxacin
experimental group2ExperimentalThe experimental group2 all oral regimen consisted of isoniazid,rifampin, pyrazinamide, and ethambutol for 4.5 months. The dosage of isoniazid,rifampin, pyrazinamide, and ethambutol is as same as that of control regimen.
Receives: Drug: Isoniazid; Drug: Rifampicin; Drug: Pyrazinamide; Drug: Ethambutol
Control regimen groupActive comparatorThe control all oral regimen consisted of isoniazid,rifampin, pyrazinamide, and ethambutol during the intensive phase of treatment (2 months), followed by isoniazid and rifampin during the continuation phase (4 months). Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg((less than 50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less than 50kg,once daily) or 1000mg (more than 50kg,once daily). .
Receives: Drug: Isoniazid; Drug: Rifampicin; Drug: Pyrazinamide; Drug: Ethambutol

What is being measured

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

  1. The percentage of participants with TB recurrence/relapse by 24 months after the end of treatment.

    Measured: 24 months after treatment completion for all 3 groups

  2. Percentage of participants with treatment failure at either 4.5 months or 6 months after randomization.

    Measured: 4.5 months after randomization for experimental group1 and 2; 6 months after randomization for control group

Secondary outcomes (5)

  1. Treatment adverse reactions occuring

    Measured: An average of 6 months for control group and 4.5 months for experimental group1 and 2 during treatment and 24 months after treatment completion.

  2. Time to sputum smear or culture conversion within intensive phase .

    Measured: An avergae of 2-3 months after randomization.

  3. Sputum smear or culture conversion proportion at the treatment completion.

    Measured: An average of 6 months for control group while 4.5 months for experimental group 1 and 2.

  4. Radiological manifestation change of TB lesion or cavity.

    Measured: An average of 6 months during treatment and 24 months after treatment completion.

  5. Patiens adherence rate

    Measured: An average of 6 months during treatment and 24 months after treatment completion.

Timeline

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

  1. First posted15 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

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
3,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02901288
Sponsor's protocol ID
2015ZX10003001
Status last verified
Mar 2017
First submitted
2 Sep 2016
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gao M, Gao J, Du J, Liu Y, Zhang Y, Ma L, Mi F, Li L, Tang S; Trial Team. Efficacy of ultra-short course chemotherapy for new smear positive drug susceptible pulmonary tuberculosis: study protocol of a multicenter randomized controlled clinical trial. BMC Infect Dis. 2017 Jun 19;17(1):435. doi: 10.1186/s12879-017-2505-7.

    PubMed 28629333

  • Pease C, Hutton B, Yazdi F, Wolfe D, Hamel C, Quach P, Skidmore B, Moher D, Alvarez GG. Efficacy and completion rates of rifapentine and isoniazid (3HP) compared to other treatment regimens for latent tuberculosis infection: a systematic review with network meta-analyses. BMC Infect Dis. 2017 Apr 11;17(1):265. doi: 10.1186/s12879-017-2377-x.

    PubMed 28399802

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Isoniazid, Rifampicin and Pyrazinamide in people with Tuberculosis, Pulmonary, run by Beijing Chest Hospital at 35 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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?

Results are not available in the source record.

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

Contact Shenjie Tang, MD (tangsj1106@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of participants with TB recurrence/relapse by 24 months after the end of treatment. (time frame: 24 months after treatment completion for all 3 groups). 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 NCT02901288, which also lists 2 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 20 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in