Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Public Health Clinical Center | OTHER_GOV |
| No.85 Hospital, Changning, Shanghai, China | OTHER |
| Ganzhou Fifth People's Hospital, China | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.
Shortening the course of treatment based on effective therapy can significantly improve patient compliance and reduce the public health burden.Research on optimal drug combination regimens to further shorten the duration and improve the efficacy of multidrug-resistant tuberculosis treatment is an important research direction.The PRS (parabolic response surface, FSC.II) system is an enhanced use of FSC to better identify and optimize optimal drug combinations.In preliminary studies, it was determined that PRS Regimens V (bedaquiline, delamanid, clofazimine, pyrazinamide)was superior to other regimens and would be a promising combination for XDR-TB because it does not contain fluoroquinolones or aminoglycosides. Preliminary trials have demonstrated that this regimen (PRS Regimens IV) can significantly reduce the duration of treatment required for MDR-TB and achieve a relapse-free cure.
Therefore, the investigators conducted an exploratory, prospective, randomized, positive-controlled, open, multicenter clinical study of this new regimen to observe the efficacy, safety, and recent relapse rate of the new regimen in the treatment of multidrug-resistant tuberculosis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Treatment according to WHO MDR-TB treatment guidelines (2019). |
|
| Group B(PRS Regimen V) | Experimental | bedaquiline, delamanid, clofazimine, pyrazinamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRS Regimen V | Drug | PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide) |
|
| Measure | Description | Time Frame |
|---|---|---|
| patient cure rate | Assessment of cure rate :
| Through study completion, an average of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Early bactericidal activity (EBA) | Collect patient sputum between 16:00 to 8:00 the next morning before taking drugs prior to treatment initiation (Day 0; D0) and on Day 2 (D2), Day 7 (D7), and Day 14 (D14) after the start of treatment | treatment initiation (Day 0; D0) and on Day 2 (D2), Day 7 (D7), and Day 14 (D14) after the start of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Presence of extrapulmonary TB (including tuberculous pleurisy);
History of allergic reaction to any of the drugs used in the study;
Presence of any of the following conditions that can lead to prolonged QT:
Pregnancy or liver, kidney, metabolic, autoimmunity, neurological, psychological or endocrine disease, blood system disease, malignant cancer, long-term users of immunosuppressant drugs.
Alcoholism
Any patients, based on the judgement of the study medical researchers who are not suitable to participate in the trial or unlikely to complete the trial.
Participating in another clinical trial at the same time.
History of non-compliance in other clinical trials.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sha wei | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25216831 | Background | Aung KJ, Van Deun A, Declercq E, Sarker MR, Das PK, Hossain MA, Rieder HL. Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis. 2014 Oct;18(10):1180-7. doi: 10.5588/ijtld.14.0100. | |
| 20442432 | Background | Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, Rieder HL. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010 Sep 1;182(5):684-92. doi: 10.1164/rccm.201001-0077OC. Epub 2010 May 4. |
| Label | URL |
|---|---|
| WHO consolidated guidelines on drug-resistant tuberculosis treatment | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
| Weifang Second People's Hospital, China |
| UNKNOWN |
| Anhui Chest Hospital | OTHER |
| Fourth Taiyuan People's Hospital, China | UNKNOWN |
| Shanghai Pudong New Area Pulmonary Hospital, China | UNKNOWN |
| Huashan Hospital | OTHER |
| The Sixth People's Hospital of Zhengzhou | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| MDR-TB Treatment Regimen(WHO) | Drug | Treatment according to WHO MDR-TB treatment guidelines (2019) |
|
|
| Time to culture positivity | culture using MGIT 960 and observe the time to detection of positive growth. | Through study completion, an average of 18 months |
| Sputum conversion rate | ompare patient sputum conversion rate between the two groups at one month and two months. | Through study completion, an average of 18 months |
| Radiology changes | "Significant absorption" is defined as lesion absorption ≥ ½. "Absorption" is defined as lesion absorption ≤ ½. "No change" if the original lesion has no clear change. "Worsened" if the original lesion is enlarged or has spread. "Closure" if the original cavity is enclosed or enclosed by blockage. "Shrinkage" if diameter of the original cavity decreased by ≥1/2. "No change" if diameter of the original cavity decreases by <1/2. "Enlarged" if diameter of the original cavity increases by >1/2. | Through study completion, an average of 18 months |
| Relapse rate one and two years after treatment completion. | follow up at 3, 6, 12, 18, and 24 months after treatment completion | At 3, 6, 12, 18, and 24 months |
| Time to Cure by Primary Endpoint criteria | Time to Cure by Primary Endpoint criteria | 6-9 month |
| 27035987 | Background | Silva A, Lee BY, Clemens DL, Kee T, Ding X, Ho CM, Horwitz MA. Output-driven feedback system control platform optimizes combinatorial therapy of tuberculosis using a macrophage cell culture model. Proc Natl Acad Sci U S A. 2016 Apr 12;113(15):E2172-9. doi: 10.1073/pnas.1600812113. Epub 2016 Mar 28. |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |