Rifampicin resistant tuberculosis
Conditions
Interventions
Pomalidomide Group (Pomalidomide OBR):Pomalidomide Lfx (Mfx), Bdq, Lzd, Cfz, Cs at least 3 drugs including Bdq were selected, and other drugs were selected from Group C
Control group:At least 3 drugs including Bdq were selected in Lfx (Mfx), Bdq, Lzd, Cfz, Cs, and other drugs were selected from group C
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those who have not taken pomalidomide; 2. Age 18-65 years old, male or female; 3. Voluntarily participate in this study and sign the informed consent form; 4. Mtb phenotype or molecular susceptibility testing showed rifampicin resistance, and chest X-ray or chest CT showed active tuberculosis lesions in the lungs; 5. Sputum smear positive for acid-fast bacteria; 6. Have not received second-line anti-tuberculosis drug treatment in the past or the treatment time is not more than 7 days; 7. Relevant tests were carried out before enrollment: alanine aminotransferase and total bilirubin were less than 2 times the upper limit of normal value; Creatinine clearance greater than 30ml/min; Neutrophils >0.5×10^9/L; Hemoglobin greater than 70g/L; Platelets greater than 50×10^9/L; 8. Negative urine pregnancy test (2 times) in women of childbearing age; 9. Commit to using two contraceptive measures at the same time for contraception during the project period.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiovascular, liver, kidney, nervous system, hematological and other diseases, as well as tumors, extensive lesions with respiratory insufficiency, diabetes mellitus and poor glycemic control (HbA1c>=7%), history of surgery within 90 days, patients with autoimmune diseases, corticosteroids or other immunological agents, biologics treatment; 2. QT interval prolongation >450ms; 3. HIV positive; 4. Patients with mental illness; 5. Those who participate in other clinical trials; 6. Pregnant or lactating women; 7. Allergy to the test drug; 8. Those with a history of thrombosis (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebral infarction) or intermediate or high risk of thrombosis assessed by VTE; 9. Those who use CYP1A2 inhibitors and P-gp inhibitors, such as fluvoxamine, ciprofloxacin, ketoconazole, etc.; 10. According to the judgment of the investigator, the subject is not suitable to participate in the project or cannot complete the whole course of the project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum negative conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Phlegm bacteria negative transfer time;Changes in sputum Mtb loading (CFU count, 16s rRNA expression).;Changes in the level of inflammation (cytokine expression).;The patient's clinical symptoms such as fever, cough, and sputum production were relieved;CT scan of the patient's lungs examined the lesions and cavitary changes; | — |
Countries
China
Contacts
Public ContactQiang Li
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed