A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Collaborators: Anhui Chest Hospital; Fourth Taiyuan People's Hospital, China; Ganzhou Fifth People's Hospital, China; Huashan Hospital; No.85 Hospital, Changning, Shanghai, China; Shanghai Public Health Clinical Center; Shanghai Pudong New Area Pulmonary Hospital, China; Weifang Second People's Hospital, China; Zhengzhou Sixth People's Hospital, China

Criteria

Inclusion Criteria:

1. Untreated newly diagnosed patients with rifampicin resistant (RR) or multidrug resistant (MDR)-TB.

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:

1. Presence of extrapulmonary TB (including tuberculous pleurisy);

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.