Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Treatments: Bedaquiline; Clofazimine; Cycloserine; Linezolid; Pyrazinamide

Criteria

Inclusion Criteria:

• Willing to participate in trial treatment and follow-up and can give informed consent

• 18-70 years old

• Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin and isoniazide confirmed by GeneXpert

• documented resistance to fluoroquinolones at screening

• Can use bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide drugs concerning the availability and costs of essential medicines

• Willing to carry out HIV testing.

• If the patient is a non-menopausal woman, agree to use or have used effective contraception during treatment.

• Have an identifiable address and stay in the area during the study period.

• Willing to follow the follow-up study procedure after the follow-up.

Exclusion Criteria:

• Combined extrapulmonary tuberculosis;

• HIV antibody positive and AIDS patients;

• Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;

• Known to be pregnant or breastfeeding;

• Unable to attend or follow treatment or follow-up time;

• Can not take oral medications;

• 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);

• Blood muscle spasm is more than 1.5 times the upper limit of normal;

• The investigator believes that there are any social or medical conditions that expose the subject to a safety hazard;

• Simultaneously apply the drugs (glucocorticoids, interferons) that affect the efficacy of this study; and apply the following drugs contraindicated with the study drug, 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 a serotonin reuptake inhibitor, a tricyclic antidepressant, a serotonin 5-HTI receptor antagonist (amitriptyline), meperidine or buspirone.

• Being allergic or intolerant of any study drug;

• Currently participating in another drug clinical trial;

• QTc interval ≥ 500 milliseconds during screening;

• Hemoglobin is less than 90g/L or platelet is less than 75*10^9/L;

• Have epilepsy, severe depression, irritability or psychosis；

• Alcohol abuse（drinking more than 64g of ethanol a day for male, 42g for female）.

• Subjects receive more than 2 weeks of bedaquiline, linezolid, cycloserine, clofazimine or pyrazinamide 3 months prior to enrolment.