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

Más betegség

• History of allergic reaction to any of the drugs used in the study;
• Pregnancy or liver, kidney, metabolic, autoimmunity, neurological, psychological or endocrine disease, blood system disease, malignant cancer, long-term users of immunosuppressant drugs.
• History of non-compliance in other clinical trials.

Laborértékek

• Presence of any of the following conditions that can lead to prolonged QT:
  • 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);
  • Pathological Q waves (any Q wave duration of > 40 ms or depth > 0.4-0.5 mV);
  • Evidence of ventricular pre-excitation (such as Wolff-Parkinson-White Syndrome);
  • EKG shows evidence of complete or clinically significant incomplete left or right bundle branch block;
  • Evidence of 2nd or 3rd degree heart block;
  • Intraventricular conduction delay, QRS durations > 120 ms;
  • Slow heart rate, defined as sinus heart rate < 50 bpm;
  • Having personal or family history of long QT syndrome;
  • Having heart disease, symptomatic or asymptomatic arrhythmia, excluding sinus arrhythmia;
  • Fainting (i.e., cardiogenic fainting, not including vasovagal syncope or seizure)
  • Having risk factors for Torsade de pointes ventricular tachycardia (e.g. heart failure, hypokalemia, hypomagnesemia)

Egyéb

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

• Untreated newly diagnosed patients with rifampicin resistant (RR) or multidrug resistant (MDR)-TB.
• 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.
• Age between 18 and 65.
• No abnormality on EKG.
• Able to understand and sign informed consent form.