Pulmonary TuberculosisNCT04187469
Efficacy and Safety of Isoniazid, Rifampicin and Moxifloxacin for the Intensive Phase of Initial Therapy of PTB
A study testing Moxifloxacin, Isoniazid, Rifampicin and Rifampicin,Isoniazid,Pyrazinamide,Ethambutol in people with Pulmonary Tuberculosis, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study aims to find an optimized initial regimen for pulmonary tuberculosis(PTB), evaluating the efficacy, safety and acceptability of isoniazid, rifampicin and moxifloxacin(HRM) for the intensive phase of initial therapy of PTB, compared with the standard initial regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Moxifloxacin, Isoniazid, Rifampicin and Rifampicin,Isoniazid,Pyrazinamide,Ethambutol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or over, and an individual who completely bear the ability of civil actions.
- New cases of pulmonary tuberculosis. No previous anti-tuberculosis therapy or cumulatively taking anti-tuberculosis drugs for less than 1 month.
- Pulmonary tuberculosis patients with bacteriological diagnosis.
Who cannot join
- Suffering from tuberculous pleurisy.
- Patients with extrapulmonary tuberculosis.
- Renal insufficiency patients with creatinine clearance rate <30 ml/min.
- Abnormal liver function (ALT and/or AST and/or TBIL greater than 2 times the upper limit of normal) or decompensated cirrhosis.
- HIV-Ab positive.
- Psychiatric patients, or have a previous history of mental illness, or recently have obvious anxiety or depression and other mental abnormalities.
Show all 16Show fewer
- Patients receiving immunosuppressive therapy.
- Pregnant or breast feeding.
- Diabetes.
- X-pert MTB/RIF test of sputum or alveolar lavage fluid showed that Mycobacterium tuberculosis was rifampin resistant.
- Moxifloxacin was used within 14 days before entering the group.
- Anti-tuberculosis treatment has been started and drugs are being taken before entering the group.
- QT interval extension > 480 ms.
- Combined with serious cardiovascular, liver, kidney, nervous system, blood system and other diseases or tumor diseases.
- Pulmonary lesions are widespread with respiratory insufficiency.
- Any other circumstances in which the anti-tuberculosis scheme of the experimental group or the control group cannot be selected for treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, 519000
Li Ding, Doctor, +8613926921192
About this study
Official title: A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis
This study aims to find an optimized initial regimen for pulmonary tuberculosis(PTB), evaluating the efficacy, safety and acceptability of isoniazid, rifampicin and moxifloxacin(HRM) for the intensive phase of initial therapy of PTB, compared with the standard initial regimen.
Read the detailed description
The standard initial regimen for PTB consists of an initial 2-month intensive phase followed by a 4-month continuation phase. In the initial 2-month intensive phase, patients have to take four drugs-isoniazid, rifampin, pyrazinamide and ethambutol (HRZE) which might cause many adverse reactions. During the intensive phase, patients are prone to poor compliance due to adverse reactions, resulting in poor outcomes and drug-resistance. Therefore, it is necessary to optimize the regimen of intensive phase to improve patients' medication compliance, so as to avoid patients' treatment failure or drug resistance.
Moxifloxacin(M) has high antibacterial activity against both intracellular and extracellular Mycobacterium tuberculosis (Mtb) with few adverse reactions and is the most promising alternative to first-line anti-TB drugs. Isoniazid and rifampin have a strong bactericidal effect on both intracellular and extracellular Mtb. In the initial regimen for PTB, isoniazid and rifampin should be used throughout the whole process. They are the key drugs to ensure the curative effect and prevent recurrence, can not be easily replaced. But pyrazinamide and ethambutol just be used in the intensive phase. Pyrazinamide has the strongest killing effect on the intracellular Mtb and mainly exerts its antibacterial effect in the first two months of treatment. Ethambutol is a bacteriostatic drug, mainly effective for rapidly growing Mtb outside cells. They can lead to severe gastrointestinal reactions, liver damage, papilledema and other adverse reactions. So moxifloxacin might be an optional substitute for pyrazinamide and ethambutol.
This study will involve comparisons that are designed to assess the short-term efficacy, safety, relapse rate one year after drug withdrawal and patients' compliance when substituting moxifloxacin for pyrazinamide and ethambutol in the existing standard regimen. Patients selected for the study will be allocated to the trial group or the control group randomly. The control group will be given six months of a standard regimen(2HRZE/4HR). The trial group will be given a total of six months of treatment, with Substitution of pyrazinamide and ethambutol with moxifloxacin during the intensive phase(2HRM/4HR).
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Moxifloxacin, Isoniazid, Rifampicin, Rifampicin,Isoniazid,Pyrazinamide,Ethambutol
- Keywords
- Pulmonary Tuberculosis, Anti-tuberculosis therapy, Intensive phase, Moxifloxacin, initial regimen
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin, Isoniazid, RifampicinDrug
Also called Avelox, Myambutol, Nydrazid, Rifampin, Rifadin
Moxifloxacin 400 mg/day, Rifampicin ≤50 kg 450 mg/day > 50 kg 600 mg/day, Isoniazid 300 mg/day.
All treatment is taken daily, for a duration of up to 6 months depending on treatment arm.
Rifampicin,Isoniazid,Pyrazinamide,EthambutolDrug
Also called Myambutol,Nydrazid,Rifampin,Rifadin
Rifampicin ≤50 kg 450 mg/day, >50 kg 600 mg/day, Isoniazid 300 mg/day, Pyrazinamide 1500mg/day, Ethambutol ≤50 kg or the elderly 750mg/day, >50 kg 1000mg/day.
All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1: 2HRM/4HR | Experimental | Two month of chemotherapy with Moxifloxacin, Isoniazid and Rifampicin, followed by four month of Isoniazid and Rifampicin only. Receives: Drug: Moxifloxacin, Isoniazid, Rifampicin |
| Regimen 2: 2HRZE/4HR (control regimen) | Active comparator | Two month of chemotherapy with Isoniazid, Rifampicin, Pyrazinamide and Ethambutol, followed by four month of Isoniazid and Rifampicin only. Receives: Drug: Rifampicin,Isoniazid,Pyrazinamide,Ethambutol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of adverse outcomes
Adverse outcomes: A sum of treatment failure and relapse.
Treatment failure: A patient whose sputum smear or culture is positive at 5 months or later during treatment.
Relapse: patients with successful treatment show one of the following conditions at any time point during the observation period of drug withdrawal: 1) Sputum or Bronchoalveolar lavage fluid(BALF)culture positive, 2) Sputum or BALF acid fast stain and/or Xpert positive with active PTB evidence in CT scan.
Measured: 18 months (within one year of completion of therapy）
Secondary outcomes (4)
The rate of Treatment success
Treatment success: A sum of cured and completed treatment.
Cure: A patient whose sputum smear or culture was positive at the beginning of the treatment but who was smear- or culture-negative in the last month of treatment and on at least one previous occasion.
Treatment completed: A patient who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion.
Measured: the 2nd, 3rd, 5th and 6th months
The rate of sputum Mtb negative conversion
Sputum Mtb negative conversion: two negative-culture results at different visits without an intervening positive result, or no sputum could be tested after once negative-culture.
Measured: the 2nd, 3rd, 5th and 6th months
The time of sputum Mtb negative conversion
The first time of sputum Mtb negative conversion
Measured: the 2nd, 3rd, 5th and 6th months
Number of Patients With Adverse Events
The number of participants includes all patients who had adverse event.
Measured: 18 months (within one year of completion of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Ding, Fifth Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Li Ding, M.D, Study director, Fifth Affiliated Hospital, Sun Yat-Sen UniversityYuanli Chen, M.Med, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen UniversityXi Liu, M.D, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen UniversityJinYu Xia, M.Med, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen UniversityZhongsi Hong, M.Med, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen UniversityJian Liu, M.D, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen UniversityMinyi Lin, M.Med, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen UniversityLisi Deng, M.Med, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187469
- Sponsor's protocol ID
- ZDWY.GRK.004
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiberi S, du Plessis N, Walzl G, Vjecha MJ, Rao M, Ntoumi F, Mfinanga S, Kapata N, Mwaba P, McHugh TD, Ippolito G, Migliori GB, Maeurer MJ, Zumla A. Tuberculosis: progress and advances in development of new drugs, treatment regimens, and host-directed therapies. Lancet Infect Dis. 2018 Jul;18(7):e183-e198. doi: 10.1016/S1473-3099(18)30110-5. Epub 2018 Mar 23.
PubMed 29580819Lange C, Chesov D, Heyckendorf J, Leung CC, Udwadia Z, Dheda K. Drug-resistant tuberculosis: An update on disease burden, diagnosis and treatment. Respirology. 2018 Jul;23(7):656-673. doi: 10.1111/resp.13304. Epub 2018 Apr 11.
PubMed 29641838Pasipanodya JG, Gumbo T. A meta-analysis of self-administered vs directly observed therapy effect on microbiologic failure, relapse, and acquired drug resistance in tuberculosis patients. Clin Infect Dis. 2013 Jul;57(1):21-31. doi: 10.1093/cid/cit167. Epub 2013 Mar 13.
PubMed 23487389Egelund EF, Alsultan A, Peloquin CA. Optimizing the clinical pharmacology of tuberculosis medications. Clin Pharmacol Ther. 2015 Oct;98(4):387-93. doi: 10.1002/cpt.180. Epub 2015 Jul 22.
PubMed 26138226Pienaar E, Sarathy J, Prideaux B, Dietzold J, Dartois V, Kirschner DE, Linderman JJ. Comparing efficacies of moxifloxacin, levofloxacin and gatifloxacin in tuberculosis granulomas using a multi-scale systems pharmacology approach. PLoS Comput Biol. 2017 Aug 17;13(8):e1005650. doi: 10.1371/journal.pcbi.1005650. eCollection 2017 Aug.
PubMed 28817561Xu P, Chen H, Xu J, Wu M, Zhu X, Wang F, Chen S, Xu J. Moxifloxacin is an effective and safe candidate agent for tuberculosis treatment: a meta-analysis. Int J Infect Dis. 2017 Jul;60:35-41. doi: 10.1016/j.ijid.2017.05.003. Epub 2017 May 8.
PubMed 28495364Gillespie SH, Crook AM, McHugh TD, Mendel CM, Meredith SK, Murray SR, Pappas F, Phillips PP, Nunn AJ; REMoxTB Consortium. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1577-87. doi: 10.1056/NEJMoa1407426. Epub 2014 Sep 7.
PubMed 25196020Chakraborty S, Rhee KY. Tuberculosis Drug Development: History and Evolution of the Mechanism-Based Paradigm. Cold Spring Harb Perspect Med. 2015 Apr 15;5(8):a021147. doi: 10.1101/cshperspect.a021147.
PubMed 25877396
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT04187469
- Acronym / sponsor ID
- ZDWY.GRK.004
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Pulmonary Tuberculosis, Anti-tuberculosis therapy, Intensive phase, Moxifloxacin, initial regimen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 5 Dec 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.
This study aims to find an optimized initial regimen for pulmonary tuberculosis(PTB), evaluating the efficacy, safety and acceptability of isoniazid, rifampicin and moxifloxacin(HRM) for the intensive phase of initial therapy of PTB, compared with the standard initial regimen.
Detailed description
The standard initial regimen for PTB consists of an initial 2-month intensive phase followed by a 4-month continuation phase. In the initial 2-month intensive phase, patients have to take four drugs-isoniazid, rifampin, pyrazinamide and ethambutol (HRZE) which might cause many adverse reactions. During the intensive phase, patients are prone to poor compliance due to adverse reactions, resulting in poor outcomes and drug-resistance. Therefore, it is necessary to optimize the regimen of intensive phase to improve patients' medication compliance, so as to avoid patients' treatment failure or drug resistance.
Moxifloxacin(M) has high antibacterial activity against both intracellular and extracellular Mycobacterium tuberculosis (Mtb) with few adverse reactions and is the most promising alternative to first-line anti-TB drugs. Isoniazid and rifampin have a strong bactericidal effect on both intracellular and extracellular Mtb. In the initial regimen for PTB, isoniazid and rifampin should be used throughout the whole process. They are the key drugs to ensure the curative effect and prevent recurrence, can not be easily replaced. But pyrazinamide and ethambutol just be used in the intensive phase. Pyrazinamide has the strongest killing effect on the intracellular Mtb and mainly exerts its antibacterial effect in the first two months of treatment. Ethambutol is a bacteriostatic drug, mainly effective for rapidly growing Mtb outside cells. They can lead to severe gastrointestinal reactions, liver damage, papilledema and other adverse reactions. So moxifloxacin might be an optional substitute for pyrazinamide and ethambutol.
This study will involve comparisons that are designed to assess the short-term efficacy, safety, relapse rate one year after drug withdrawal and patients' compliance when substituting moxifloxacin for pyrazinamide and ethambutol in the existing standard regimen. Patients selected for the study will be allocated to the trial group or the control group randomly. The control group will be given six months of a standard regimen(2HRZE/4HR). The trial group will be given a total of six months of treatment, with Substitution of pyrazinamide and ethambutol with moxifloxacin during the intensive phase(2HRM/4HR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen 1: 2HRM/4HR | Experimental | Drug: Moxifloxacin, Isoniazid, RifampicinTwo month of chemotherapy with Moxifloxacin, Isoniazid and Rifampicin, followed by four month of Isoniazid and Rifampicin only. |
| Regimen 2: 2HRZE/4HR (control regimen) | Active comparator | Drug: Rifampicin,Isoniazid,Pyrazinamide,EthambutolTwo month of chemotherapy with Isoniazid, Rifampicin, Pyrazinamide and Ethambutol, followed by four month of Isoniazid and Rifampicin only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or over, and an individual who completely bear the ability of civil actions.
- New cases of pulmonary tuberculosis. No previous anti-tuberculosis therapy or cumulatively taking anti-tuberculosis drugs for less than 1 month.
- Pulmonary tuberculosis patients with bacteriological diagnosis.
Key exclusion criteria (16 listed)
- Suffering from tuberculous pleurisy.
- Patients with extrapulmonary tuberculosis.
- Renal insufficiency patients with creatinine clearance rate <30 ml/min.
- Abnormal liver function (ALT and/or AST and/or TBIL greater than 2 times the upper limit of normal) or decompensated cirrhosis.
- HIV-Ab positive.
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 |
|---|---|---|
| Moxifloxacin, Isoniazid, RifampicinAlso: Avelox, Myambutol, Nydrazid, Rifampin, RifadinMoxifloxacin 400 mg/day, Rifampicin ≤50 kg 450 mg/day > 50 kg 600 mg/day, Isoniazid 300 mg/day. All treatment is taken daily, for a duration of up to 6 months depending on treatment arm. | Drug | Regimen 1: 2HRM/4HR |
| Rifampicin,Isoniazid,Pyrazinamide,EthambutolAlso: Myambutol,Nydrazid,Rifampin,RifadinRifampicin ≤50 kg 450 mg/day, >50 kg 600 mg/day, Isoniazid 300 mg/day, Pyrazinamide 1500mg/day, Ethambutol ≤50 kg or the elderly 750mg/day, >50 kg 1000mg/day. All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm. | Drug | Regimen 2: 2HRZE/4HR (control regimen) |
Primary outcome
The rate of adverse outcomes
Time frame: 18 months (within one year of completion of therapy）
Adverse outcomes: A sum of treatment failure and relapse. Treatment failure: A patient whose sputum smear or culture is positive at 5 months or later during treatment. Relapse: patients with successful treatment show one of the following conditions at any time point during the observation period of drug withdrawal: 1) Sputum or Bronchoalveolar lavage fluid(BALF)culture positive, 2) Sputum or BALF acid fast stain and/or Xpert positive with active PTB evidence in CT scan.
4 secondary outcomes
The rate of Treatment success
Time frame: the 2nd, 3rd, 5th and 6th months
The rate of sputum Mtb negative conversion
Time frame: the 2nd, 3rd, 5th and 6th months
The time of sputum Mtb negative conversion
Time frame: the 2nd, 3rd, 5th and 6th months
Number of Patients With Adverse Events
Time frame: 18 months (within one year of completion of therapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Background: PubMed 29580819Tiberi S, du Plessis N, Walzl G, Vjecha MJ, Rao M, Ntoumi F, Mfinanga S, Kapata N, Mwaba P, McHugh TD, Ippolito G, Migliori GB, Maeurer MJ, Zumla A. Tuberculosis: progress and advances in development of new drugs, treatment regimens, and host-directed therapies. Lancet Infect Dis. 2018 Jul;18(7):e183-e198. doi: 10.1016/S1473-3099(18)30110-5. Epub 2018 Mar 23.
- Background: PubMed 29641838Lange C, Chesov D, Heyckendorf J, Leung CC, Udwadia Z, Dheda K. Drug-resistant tuberculosis: An update on disease burden, diagnosis and treatment. Respirology. 2018 Jul;23(7):656-673. doi: 10.1111/resp.13304. Epub 2018 Apr 11.
- Background: PubMed 23487389Pasipanodya JG, Gumbo T. A meta-analysis of self-administered vs directly observed therapy effect on microbiologic failure, relapse, and acquired drug resistance in tuberculosis patients. Clin Infect Dis. 2013 Jul;57(1):21-31. doi: 10.1093/cid/cit167. Epub 2013 Mar 13.
- Background: PubMed 26138226Egelund EF, Alsultan A, Peloquin CA. Optimizing the clinical pharmacology of tuberculosis medications. Clin Pharmacol Ther. 2015 Oct;98(4):387-93. doi: 10.1002/cpt.180. Epub 2015 Jul 22.
- Background: PubMed 28817561Pienaar E, Sarathy J, Prideaux B, Dietzold J, Dartois V, Kirschner DE, Linderman JJ. Comparing efficacies of moxifloxacin, levofloxacin and gatifloxacin in tuberculosis granulomas using a multi-scale systems pharmacology approach. PLoS Comput Biol. 2017 Aug 17;13(8):e1005650. doi: 10.1371/journal.pcbi.1005650. eCollection 2017 Aug.
- Background: PubMed 28495364Xu P, Chen H, Xu J, Wu M, Zhu X, Wang F, Chen S, Xu J. Moxifloxacin is an effective and safe candidate agent for tuberculosis treatment: a meta-analysis. Int J Infect Dis. 2017 Jul;60:35-41. doi: 10.1016/j.ijid.2017.05.003. Epub 2017 May 8.
- Background: PubMed 25196020Gillespie SH, Crook AM, McHugh TD, Mendel CM, Meredith SK, Murray SR, Pappas F, Phillips PP, Nunn AJ; REMoxTB Consortium. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1577-87. doi: 10.1056/NEJMoa1407426. Epub 2014 Sep 7.
- Background: PubMed 25877396Chakraborty S, Rhee KY. Tuberculosis Drug Development: History and Evolution of the Mechanism-Based Paradigm. Cold Spring Harb Perspect Med. 2015 Apr 15;5(8):a021147. doi: 10.1101/cshperspect.a021147.
- Definitions and reporting framework for tuberculosisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Li Ding, M.D study director
Fifth Affiliated Hospital, Sun Yat-Sen University
Yuanli Chen, M.Med principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University
Xi Liu, M.D principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxifloxacin, Isoniazid, Rifampicin and Rifampicin,Isoniazid,Pyrazinamide,Ethambutol in people with Pulmonary Tuberculosis, run by Fifth Affiliated Hospital, Sun Yat-Sen University 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 16 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 5 Dec 2019. 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.
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 Li Ding, M.D (13926921192, dingli@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of adverse outcomes (time frame: 18 months (within one year of completion of therapy）). 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 NCT04187469, which also lists 8 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 5 Dec 2019.