Pulmonary tuberculosis
Conditions
Interventions
Intervention Group (Novel Regimen Group):The standard regimen is combined with sulfasalazine
Control Group (Standard Regimen Group):Standard regimen anti-tuberculosis treatment
Sponsors
The Third People’s Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Aged over 18 years old; 2.Adult patients with etiologically confirmed active tuberculosis and susceptibility to first-line anti-tuberculosis drugs; 3.With good treatment compliance and follow-up accessibility; 4.Voluntarily participating in the study, signing the informed consent form, and willing to cooperate with biological sample collection.
Exclusion criteria
Exclusion criteria: 1.Known or suspected drug resistance to the core study drugs (isoniazid, rifamycins, ethambutol, pyrazinamide), or inability to rule out the risk of drug resistance before randomization; 2.Extrapulmonary tuberculosis requiring prolonged or special treatment: miliary tuberculosis, tuberculous meningitis/meningoencephalitis, spinal/osteoarticular tuberculosis, abdominal tuberculosis, genitourinary tuberculosis, pericardial tuberculosis, etc; 3.Strong clinical evidence suggesting nontuberculous mycobacterial (NTM) pulmonary disease during the screening period; 4.Abnormal laboratory test results within 14 days prior to enrollment: (1).Liver function abnormality: ALT or AST >= 3× upper limit of normal (ULN), or total bilirubin (TBIL) >= 2× ULN; (2).Renal insufficiency: serum creatinine >= 2× ULN or estimated glomerular filtration rate (eGFR) 5.5 mmol/L (hypokalemia is allowed to be re-tested once after correction; eligible subjects can be enrolled if retest results are normal). 5.Allergy to sulfasalazine and its metabolites, sulfonamides or salicylic acid; glucose-6-phosphate dehydrogenase (G6PD) deficiency; 6.Drug-drug interaction: long-term mandatory use of drugs with severe interactions with rifamycins for which no alternative medication is available; 7.Immunosuppression and special conditions: HIV positivity; systemic glucocorticoid therapy administered within 2 weeks prior to enrollment; ongoing use of immunosuppressants/biological agents; or diagnosis of severe autoimmune diseases; 8.Pregnancy or lactation: female subjects who are pregnant or breastfeeding; 9.Presence of severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acid-fast staining;Mycobacterium tuberculosis culture;Chest CT / Chest X-ray data; | — |
Countries
China
Contacts
Public ContactPeize Zhang
The Third People’s Hospital of Shenzhen
Outcome results
None listed