A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB
NCT ID: NCT05278988
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2021-04-01
2024-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Treatment according to WHO MDR-TB treatment guidelines (2019).
MDR-TB Treatment Regimen(WHO)
Treatment according to WHO MDR-TB treatment guidelines (2019)
Group B(PRS Regimen V)
bedaquiline, delamanid, clofazimine, pyrazinamide
PRS Regimen V
PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)
Interventions
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PRS Regimen V
PRS Regimen V(bedaquiline, delamanid, clofazimine, pyrazinamide)
MDR-TB Treatment Regimen(WHO)
Treatment according to WHO MDR-TB treatment guidelines (2019)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Newly treated patients: at least twice confirmed by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB; Retreated patients: confirmed once by molecular biology or phenotypic drug susceptibility test to have RR- or MDR-TB.
3. Age between 18 and 65.
4. No abnormality on EKG.
5. Able to understand and sign informed consent form.
Exclusion Criteria
2. History of allergic reaction to any of the drugs used in the study;
3. Presence of any of the following conditions that can lead to prolonged QT:
1. During screening process, ECG shows QT or QTc interval ≥ 450 ms (permit one non-prescheduled retest within the screening period to re-evaluate the testees' qualification);
2. Pathological Q waves (any Q wave duration of \> 40 ms or depth \> 0.4-0.5 mV);
3. Evidence of ventricular pre-excitation (such as Wolff-Parkinson-White Syndrome);
4. EKG shows evidence of complete or clinically significant incomplete left or right bundle branch block;
5. Evidence of 2nd or 3rd degree heart block;
6. Intraventricular conduction delay, QRS durations \> 120 ms;
7. Slow heart rate, defined as sinus heart rate \< 50 bpm;
8. Having personal or family history of long QT syndrome;
9. Having heart disease, symptomatic or asymptomatic arrhythmia, excluding sinus arrhythmia;
10. Fainting (i.e., cardiogenic fainting, not including vasovagal syncope or seizure)
11. Having risk factors for Torsade de pointes ventricular tachycardia (e.g. heart failure, hypokalemia, hypomagnesemia)
4. Pregnancy or liver, kidney, metabolic, autoimmunity, neurological, psychological or endocrine disease, blood system disease, malignant cancer, long-term users of immunosuppressant drugs.
5. Alcoholism
6. 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.
7. Participating in another clinical trial at the same time.
8. History of non-compliance in other clinical trials.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Public Health Clinical Center
OTHER_GOV
No.85 Hospital, Changning, Shanghai, China
OTHER
Ganzhou Fifth People's Hospital, China
UNKNOWN
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
Zhengzhou Sixth People's Hospital, China
UNKNOWN
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Wei Sha MD & PhD
Director, Head of Tuberculosis Department,Shanghai Pulmonary Hospital, Principal Investigator, Clinical Professor
Principal Investigators
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Sha wei
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Locations
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Shanghai Pulmonary Hospital
Shanghai, , China
Countries
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References
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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.
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.
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.
Related Links
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WHO consolidated guidelines on drug-resistant tuberculosis treatment
Other Identifiers
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K21-024
Identifier Type: -
Identifier Source: org_study_id