Reinfection Pulmonary TuberculosisPhase 4NCT02331823
Research on New Regimens for Retreatment Pulmonary Tuberculosis
A Phase 4 study testing Isoniazid Aminosalicylate Tablets and Streptomycin injectable in people with Reinfection Pulmonary Tuberculosis, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients. To obtain optimized short-course regimen, decrease treatment cost and improve success rate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reinfection Pulmonary Tuberculosis
- What is being tested?
- Isoniazid Aminosalicylate Tablets and Streptomycin injectable
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2016
- 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
- Sputum confirmed diagnosis of retreatment pulmonary tuberculosis
- Must be able to swallow tablets
- Must be able to sign written informed consent form
Who cannot join
- Extra-pulmonary tuberculosis
- Diabetes
- Allergy to any of the medications in the regimen or pregnancy
- Liver disease
- Renal disease
- Metabolic disease
Show all 14Show fewer
- Immune system disease
- Hematological disease
- Nervous system and mental disease
- Endocrine disease
- Malignant disease
- Receiving immunosuppressive therapy
- HIV/AIDS
- Alcohol addiction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Qing Zhang, M.D, 8621-65115006 ext. 2002, zhqi709851@sohu.com
Wei Sha, M.D, 8621-65115006 ext. 2017, shfksw@126.com
About this study
Official title: New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis
Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients.
To obtain optimized short-course regimen, decrease treatment cost and improve success rate.
Read the detailed description
China is the country with the second highest Tuberculosis (TB) burden in the world. Most of the retreatment TB patients may develop multi-drug resistant. The resistant rate of any of the anti-TB drug is 35.9%, and the multi-drug resistant rate is 15.4%. Retreatment TB becomes one of the factors which inhibit the decrease of morbidity and mortality of TB. It is also a tuff work in TB control. At present the standardized regimen for retreatment TB is 2SHREZ/6HRE or 3HREZ/6HRE. The drugs in the regimen are all first-line anti-TB drugs which are unsuitable for the high drug resistance prevalence, because the cure rate of this regimen is low and the adverse reaction is severe.
Our study is a national multi-center, prospective trail to investigate the efficacy of a new super-short regimen for retreatment TB patients. The new regimen consists of 5 drugs lasting 5 months. The cure rate and success rate of the new regimen is compared with standardized regimen usually 8-9 months in order to obtain the optimized regimen.
- Conditions
- Reinfection Pulmonary Tuberculosis
- Being tested
- Isoniazid Aminosalicylate Tablets, Streptomycin injectable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoniazid Aminosalicylate TabletsDrug
Also called ethambutol tablets, pyrazinamide tablets, rifabutin capsules, moxifloxacin tablets
a regimen consists of 5 anti-TB drugs (Isoniazid Aminosalicylate Tablets+pyrazinamide tablets+ethambutol tablets+rifabutin capsules+moxifloxacin tablets)to treat retreatment pulmonary tuberculosis patients. The total treatment course is 5 months.
Streptomycin injectableDrug
Also called isoniazid tablets, ethambutol tablets, rifampicin capsules, pyrazinamide tablets
standardized regimen 2 months of streptomycin injectable + isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules or 3 months of isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules to treat Arm B patients as a control to arm A.The treatment course is 8-9 months.
| Study group | Role | What they receive |
|---|---|---|
| arm A: super-short retreatment regimen | Experimental | A regimen of 5 drugs is to be administered. Isoniazid Aminosalicylate Tablets,0.3g tid po for 5 mon moxifloxacin tab, 0.4g qd po for 5 mon rifabutin capsule,0.3g qd po for 5 mon ethambutol tab, 0.75g qd po for 5 mon pyrazinamide tab, 0.5g tid po for 5 mon Receives: Drug: Isoniazid Aminosalicylate Tablets |
| arm B:standardized retreatment regimen | Active comparator | 8-9 months of standardized regimen is to be administered. regimen 1.2SHREZ/6HRE streptomycin injectable,0.75g qd intramuscular for 2 mon isoniazid tab,0.3g qd po for 8 mon rifampicin capsule,0.45-0.6g po for 8 mon ethambutol tab, 0.75g qd po for 8 mon pyrazinamide tab, 0.5g tid po for 2 mon or regimen 2.3HREZ/6HRE isoniazid tab,0.3g qd po for 9 mon rifampicin capsule,0.45-0.6g po for 9 mon ethambutol tab, 0.75g qd po for 9 mon pyrazinamide tab, 0.5g tid po for 3 mon Receives: Drug: Streptomycin injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
Measured: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.
Secondary outcomes (1)
adverse reaction rate
Measured: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
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 Reinfection Pulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Center for Disease Control and Prevention, Jiangsu Province Centers for Disease Control and Prevention, Zhejiang University, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Qing Zhang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Heping Xiao, M.D, Principal investigator, Shanghai Pulmonary Hospital,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331823
- Sponsor's protocol ID
- 2013ZX10003009
- Status last verified
- Jan 2015
- First submitted
- 31 Dec 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yan L, Kan X, Zhu L, Xu K, Yin J, Jie L, Li Y, Yue J, Cui W, Du J, Wang L, Tan S, Jiang X, Zeng Z, Xu S, Wang L, Chen Y, He W, Gao X, Bai D, Zhao C, Yan X, Zhu Y, Fan Y, Xie L, Deng A, Zhang Q, Xiao H. Short-course Regimen for Subsequent Treatment of Pulmonary Tuberculosis: A Prospective, Randomized, Controlled Multicenter Clinical Trial in China. Clin Ther. 2018 Mar;40(3):440-449. doi: 10.1016/j.clinthera.2018.01.013. Epub 2018 Mar 6.
PubMed 29519716
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT02331823
- Acronym / sponsor ID
- 2013ZX10003009
- Conditions
- Reinfection Pulmonary Tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Shanghai Center for Disease Control and Prevention, Jiangsu Province Centers for Disease Control and Prevention, Zhejiang University, Centers for Disease Control and Prevention
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- 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.
Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients.
To obtain optimized short-course regimen, decrease treatment cost and improve success rate.
Detailed description
China is the country with the second highest Tuberculosis (TB) burden in the world. Most of the retreatment TB patients may develop multi-drug resistant. The resistant rate of any of the anti-TB drug is 35.9%, and the multi-drug resistant rate is 15.4%. Retreatment TB becomes one of the factors which inhibit the decrease of morbidity and mortality of TB. It is also a tuff work in TB control. At present the standardized regimen for retreatment TB is 2SHREZ/6HRE or 3HREZ/6HRE. The drugs in the regimen are all first-line anti-TB drugs which are unsuitable for the high drug resistance prevalence, because the cure rate of this regimen is low and the adverse reaction is severe.
Our study is a national multi-center, prospective trail to investigate the efficacy of a new super-short regimen for retreatment TB patients. The new regimen consists of 5 drugs lasting 5 months. The cure rate and success rate of the new regimen is compared with standardized regimen usually 8-9 months in order to obtain the optimized regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm A: super-short retreatment regimen | Experimental | Drug: Isoniazid Aminosalicylate TabletsA regimen of 5 drugs is to be administered. Isoniazid Aminosalicylate Tablets,0.3g tid po for 5 mon moxifloxacin tab, 0.4g qd po for 5 mon rifabutin capsule,0.3g qd po for 5 mon ethambutol tab, 0.75g qd po for 5 mon pyrazinamide tab, 0.5g tid po for 5 mon |
| arm B:standardized retreatment regimen | Active comparator | Drug: Streptomycin injectable8-9 months of standardized regimen is to be administered. regimen 1.2SHREZ/6HRE streptomycin injectable,0.75g qd intramuscular for 2 mon isoniazid tab,0.3g qd po for 8 mon rifampicin capsule,0.45-0.6g po for 8 mon ethambutol tab, 0.75g qd po for 8 mon pyrazinamide tab, 0.5g tid po for 2 mon or regimen 2.3HREZ/6HRE isoniazid tab,0.3g qd po for 9 mon rifampicin capsule,0.45-0.6g po for 9 mon ethambutol tab, 0.75g qd po for 9 mon pyrazinamide tab, 0.5g tid po for 3 mon |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sputum confirmed diagnosis of retreatment pulmonary tuberculosis
- Must be able to swallow tablets
- Must be able to sign written informed consent form
Key exclusion criteria (14 listed)
- Extra-pulmonary tuberculosis
- Diabetes
- Allergy to any of the medications in the regimen or pregnancy
- Liver disease
- Renal disease
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 |
|---|---|---|
| Isoniazid Aminosalicylate TabletsAlso: ethambutol tablets, pyrazinamide tablets, rifabutin capsules, moxifloxacin tabletsa regimen consists of 5 anti-TB drugs (Isoniazid Aminosalicylate Tablets+pyrazinamide tablets+ethambutol tablets+rifabutin capsules+moxifloxacin tablets)to treat retreatment pulmonary tuberculosis patients. The total treatment course is 5 months. | Drug | arm A: super-short retreatment regimen |
| Streptomycin injectableAlso: isoniazid tablets, ethambutol tablets, rifampicin capsules, pyrazinamide tabletsstandardized regimen 2 months of streptomycin injectable + isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules or 3 months of isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules to treat Arm B patients as a control to arm A.The treatment course is 8-9 months. | Drug | arm B:standardized retreatment regimen |
Primary outcome
success rate
Time frame: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.
1 secondary outcome
adverse reaction rate
Time frame: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Derived from this study: PubMed 29519716Yan L, Kan X, Zhu L, Xu K, Yin J, Jie L, Li Y, Yue J, Cui W, Du J, Wang L, Tan S, Jiang X, Zeng Z, Xu S, Wang L, Chen Y, He W, Gao X, Bai D, Zhao C, Yan X, Zhu Y, Fan Y, Xie L, Deng A, Zhang Q, Xiao H. Short-course Regimen for Subsequent Treatment of Pulmonary Tuberculosis: A Prospective, Randomized, Controlled Multicenter Clinical Trial in China. Clin Ther. 2018 Mar;40(3):440-449. doi: 10.1016/j.clinthera.2018.01.013. Epub 2018 Mar 6.
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.
Heping Xiao, M.D principal investigator
Shanghai Pulmonary Hospital,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isoniazid Aminosalicylate Tablets and Streptomycin injectable in people with Reinfection Pulmonary Tuberculosis, 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 3 inclusion and 14 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 6 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Zhang, M.D (8621-65115006 ext. 2002, zhqi709851@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment.). 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 NCT02331823, 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 6 Jan 2015.