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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)
Treatment according to WHO MDR-TB treatment guidelines (2019)
Shanghai Pulmonary Hospital
Shanghai, China
patient cure rate
Assessment of cure rate : 1. Cure. 2. Treatment completion. 3. Treatment failure. 4. Death. 5. Loss. 6. Inconclusive. 7. Treatment success.
Time frame: Through study completion, an average of 18 months
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
Time frame: treatment initiation (Day 0; D0) and on Day 2 (D2), Day 7 (D7), and Day 14 (D14) after the start of treatment
Time to culture positivity
culture using MGIT 960 and observe the time to detection of positive growth.
Time frame: 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.
Time frame: 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.
Time frame: 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
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Time frame: At 3, 6, 12, 18, and 24 months
Time to Cure by Primary Endpoint criteria
Time to Cure by Primary Endpoint criteria
Time frame: 6-9 month