Pulmonary infection of Mycobacterium abscess
Conditions
Interventions
Contezolid group:Contizolamide was given on the basis of the basic treatment regimen
Linezolid group:Linezolid tablets were given on the basis of the basic treatment regimen
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, male or female; 2. All enrolled patients were required to meet clinical, microbiological and imaging diagnostic criteria for pulmonary infection of Mycobacterium abscess as specified in ATS/ IDSA guidelines, and were diagnosed as pulmonary infection caused by Mycobacterium abscess; 3. Antibiotic sensitivity tests using standard techniques show that all test drugs are sensitive or mediators; 4. Female subjects must meet the following conditions: ? have been postmenopausal for at least one year, ? have undergone sterilization, or ? fertile subjects must meet the following conditions: negative urine pregnancy test at the time of admission, reliable contraception during the test period, non-lactation period; Male and female subjects were required to use effective contraception during the study period and one month after the study. 5. Subjects (or their legal agent/guardian) understand the study procedure and content, voluntarily sign the informed consent, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Allergic to any drugs in the regimen; 2. Sputum culture or other sample culture results showed multiple NTM or bacteria mixed infection; 3. Patients should not receive systematic anti-mycobacterium therapy within 3 months prior to screening; 4. The patient had received oxazolidinone antibiotics within 2 weeks prior to screening; 5. The patient had received corticosteroid therapy within 4 weeks prior to screening 6. Poor blood sugar control; 7. Hiv-infected persons; 8. Absolute neutrophil count at screening =500/µL; 9. The patient has extrapulmonary infection or systemic NTM infection; 10. Participated in other clinical studies 8 weeks before the start of the experiment; 11. Active tuberculosis; 12. Patients with serious diseases such as active malignancies (primary or metastatic) or any malignancies requiring chemotherapy or radiotherapy during the screening or study period; 13. Patients with severe liver and kidney dysfunction (total bilirubin > at screening;3 times the upper limit of normal, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 5 times the upper limit of normal [ULN]);Oliguria with eGFR 2 times the upper limit of normal or no response to fluid replacement <20 mL/ hour or any form of dialysis); 14. Patients during pregnancy and lactation; 15. Patients unable to perform the 6-minute walking test (6MWT); 16. Patients with a history of lung transplantation; 17. The survival of patients was expected to be < 12 months; 18. Severely infected patients or doctors consider patients to have other conditions that make them unfit to participate in clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| electrocardiogram;Blood routine;Blood biochemistry;Coagulation function;Urine routine;Optical test - visual field of color vision;Subjective peripheral neuropathy score;St. George's Breathing questionnaire score;the rate of AESE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriological examination;Semi-quantitative bacteriological culture; | — |
Countries
China
Contacts
Public ContactHaiqing Chu
Shanghai Pulmonary Hospital
Outcome results
None listed