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| Name | Class |
|---|---|
| West China Hospital | OTHER |
| Wuhan Pulmonary Hospital | OTHER |
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A randomized, open, drug controlled design of experiments was used to evaluate the early bactericidal activity, safety, tolerance and pharmacokinetic characteristics of JDB0131 benzenesulfonate tablet taken orally by drug sensitive pulmonary tuberculosis patients. Five groups are proposed to be set up in this test (JDB0131 benzenesulfonate 100mg BID, JDB0131 benzenesulfonate 200mg QD, JDB0131 benzenesulfonate 200mg BID, anti tuberculosis drug fixed dose composite dosage QD is determined according to the weight of the study participants, and delamanid 100mg BID)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First group | Experimental | JDB0131 Benzenesulfonate tablets,100mg BID group,12 cases |
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| Second group | Experimental | JDB0131 Benzenesulfonate tablets 200mg QD group,12 cases |
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| Third group | Experimental | JDB0131 Benzenesulfonate tablets 200mg BID group,12 cases |
|
| Forth group | Active Comparator | Ethylpyrazine rifampicide (II) QD group,8 cases |
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| Fifth group | Active Comparator | Delamanid Tablets 100mg BID group,8 cases |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JDB0131 | Drug | JDB0131 benzenesulfonate is a new anti tuberculosis compound based on delamanid. According to the existing results of pre clinical in vitro activity, in vivo efficacy, pharmacokinetics and safety in human body, JDB0131 benzenesulfonate has the same in vivo efficacy, better lung tissue distribution and better safety as delamanid. In December 2016, JDB0131 obtained the drug clinical approval issued by the CFDA, and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation. |
| Measure | Description | Time Frame |
|---|---|---|
| EBA | Early bactericidal activity (EBA), counted by daily log (CFU) change | he change of TB bacterium burden in sputum from Day 0 to Day 2 and/or Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the investigator. | average of 6 month |
| Percentage of Participants With Immediately Reportable Events (IREs) |
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Inclusion Criteria:
(Those who must meet all the selection criteria can enter the group)
Exclusion Criteria:
(Meet any of the following criteria will be excluded)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naihui Chu, Dr. | Contact | +86 13611326573 | dongchu1994@sina.com | |
| Mailing Huang, Dr. | Contact | +86 13720046915 | Huangmailing@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Chest Hospital (Wuhan Institute For Tuberculosis Control) | Recruiting | Wuhan | Hubei | 430014 | China |
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| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| C516022 | OPC-67683 |
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| Delamanid | Drug | Delamanid is a new drug developed by Otsuka Pharmaceutical Co., Ltd. in Japan to treat multidrug resistant tuberculosis. In 2014, Delamanid was conditionally approved for marketing by the European Medicines Agency and recommended for use in adult MDR-TB patients who cannot form an effective regimen due to drug resistance or tolerance reasons. In the same year, WHO recommended that Delamanid be conditionally used for long-term treatment of adult MDR-TB. In 2016, the WHO recommended widening the age range for Delamanid to 6-17 years old. In March 2018, Delamanid was listed in China. |
|
| Ethylpyrazine rifampicide (II) | Drug | Ethylpyrazine rifampicide (II) is suitable for the first two months of intensive treatment of pulmonary tuberculosis with short-term therapy. This product is a compound preparation, consisting of 0.15g of rifampicin (C43H58N4O12), 0.075g of isoniazid (C6H7N3O), 0.4g of pyrazinamide (C5H5N3O), and 0.275g of ethambutol hydrochloride (C10H24N2O2 · 2HCl) per tablet. |
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An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-participant hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above. The following were considered as IREs- serious adverse events (SAEs), pregnancies in trial participants or their partners, and all events involving overdose, misuse and abuse.problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the investigator. |
| average of 6 month |
| ECG | ECG QT Interval | an average of 6 month |
| Safe tolerance | laboratory tests | through study completion, an average of 6 month |
| Safe tolerance | Eye examination and depression scale scores | through study completion, an average of 6 month |
| Tmax | Time to Reach Maximal Peak Plasma Concentration for JDB0131 | Day 0 to Day 21 |
| Cmax | Maximal Peak Plasma Concentration for JDB0131 | Day 0 to Day 21 |
| AUC0-24h | Area under plasma concentration time curve from initial administration to 12 hours for JDB0131 | Day 0 to Day 21 |
| T Tss,max | Steady state peak time for JDB0131 | Day 0 to Day 21 |
| Css,max | Steady state peak concentration for JDB0131 | Day 0 to Day 21 |
| Css,min | Steady-state valley concentration for JDB0131 | Day 0 to Day 21 |
| Css,avg | Mean steady-state blood drug concentration for JDB0131 | Day 0 to Day 21 |
| t1/2,ss | Elimination half life for JDB0131 | Day 0 to Day 21 |
| AUC0-12,ss | Area under the plasma concentration time curve from the last administration to 12 hours for JDB0131 | Day 0 to Day 21 |
| AUC0-t,ss | Area under the plasma concentration-time curve from the last dose to the last measurable concentration time "t" for JDB0131 | Day 0 to Day 21 |
| AUC0-∞,ss | Area under the plasma concentration-time curve from the last dose extrapolated to infinity for JDB0131 | Day 0 to Day 21 |
| Vd,ss | Apparent volume of distribution for JDB0131 | Day 0 to Day 21 |
| CL,ss | Oral clearance for JDB0131 | Day 0 to Day 21 |
| Rac(Cmax) | Ratio of Cmax,ss at day 14 to Cmax at day 1 | Day 0 to Day 21 |
| Rac(AUC) | AUC0-12,ss at day 14 compared to AUC0-12 at day 1 | Day 0 to Day 21 |
| Fluctuation coefficient | Percent fluctuation at steady state = 100 * (Css, max - Css, min) / Css, avg. | Day 0 to Day 21 |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |