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Table 2 TB-TRUST inclusion and exclusion criteria

From: Refining MDR-TB treatment regimens for ultra short therapy (TB-TRUST): study protocol for a randomized controlled trial

  Detailed Description
Inclusion criteria 1) Willing to participate in trial treatment, follow-up and sign informed consent
2) Age 18–70 years old
3) Smear-positive pulmonary tuberculosis with resistance to rifampicin confirmed by Xpert® MTB/RIF (Cepheid, Sunnyvale, CA, USA)
4) Willing to carry out HIV testing
5) If a non-menopausal woman, willing to use or have used effective contraception during treatment
6) Have an identifiable address and stay in the area during the study period
7) Willing to follow the follow-up study procedure after the follow-up.
Exclusion criteria 1) Resistant to second-line injection confirmed by Xpert® MTB/XDR (Cepheid, Sunnyvale, CA, USA)
2) Resistant to fluoroquinolone confirmed by Xpert® MTB/XDR
3) Combined extrapulmonary tuberculosis
4) HIV antibody positive and AIDS patients
5) Severe patients and impossible to survive for more than 16 weeks according to the judgment of the research physician
6) Have been pregnant or breastfeeding
7) Unable to attend or follow treatment or follow-up time
8) Cannot take oral medications
9) Patients with impaired liver function (hepatic encephalopathy, ascites; total bilirubin is more than 2 times higher than the upper limit of normal; ALT or AST is more than 5 times the upper limit of normal)
10) Blood creatinine is more than 1.5 times the upper limit of normal
11) The investigator believes that there are any social or medical harms that expose to the participants
12) Simultaneously apply the drugs (glucocorticoids, interferons) that affect the efficacy of this study; and apply the following drugs contraindicated with the study regimens, including non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors (phenethyl hydrazine, different Carbofurs et al), direct or indirect sympathomimetic drugs (such as pseudoephedrine), vasopressor drugs (such as: adrenaline, norepinephrine), dopamine drugs (such as: dopamine, dobutamine), 5-HI reuptake inhibitor, a tricyclic antidepressant, a 5-HTI receptor antagonist (amitriptyline), meperidine or buspirone
13) Being allergic or intolerant of any study drug
14) Currently participating in another drug clinical trial
15) QTc interval ≥ 500 ms during screening
16) Hemoglobin is less than 90 g/L or platelet is less than 75*10^9/L
17) Have epilepsy, severe depression, irritability or psychosis
18) Alcohol abuse