Mycobacterium abscessusLung Disease
Conditions
Interventions
Phase I Experimental Group (A):Ceftobiprole Administration: 500 mg per dose (based on the approved prescribing information and our preclinical animal study data), administered by intravenous infusion
Phase I Control Group (B):Control Group Intervention
Clarithromycin monotherapy: 1.0g once daily (orally), with a treatment duration of 15 days.
Phase II Experimental Group (C):The experimental group received a 4-week combination therapy comprising ceftobiprole (500 mg every 8 hours via intravenous injection, with dosing frequency adjustable b
Phase II Control Group (D):The control group received a 4-week combination therapy consisting of clarithromycin (1.0 g orally once daily), amikacin (0.4 g via intravenous or intramuscular injection on
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–70 years, regardless of gender.?? 2.? Body mass index (BMI) of 18.5–30.0 kg/m².?? 3.? Clinical history meeting the diagnostic criteria for Mycobacterium abscessuslung disease.?? 4.? History of mycobacterial lung disease =1 year, with treatment necessity confirmed by physicians according to the Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases.?? 5.? Sputum smear positive (1+) or higher (confirmed by acid-fast bacilli microscopy).?? 6. Capable of understanding and signing the informed consent form.?
Exclusion criteria
Exclusion criteria: 1.? HIV infection.?? 2.? Autoimmune diseases.?? 3.? Diagnosis of malignancy.?? 4. ?Impaired hepatic or renal function.?? 5.? Concurrent extrapulmonary nontuberculous mycobacterial (NTM) infection.?? 6.? Known hypersensitivity to:?•Ceftobiprole or any excipients listed in the [ingredients] section;•Cephalosporin antibiotics;•Other ß-lactams (e.g., penicillins, monobactams, carbapenems). 7.? Pregnancy or lactation.??8.Any condition deemed unsuitable for participation by the investigator.?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early bactericidal activity,EBA;Time to negative conversion of acid-fast bacilli smear and mycobacterial culture; | — |
Secondary
| Measure | Time frame |
|---|---|
| pulmonary imaging absorption changes? after antibiotic therapy;Clinical Manifestations; | — |
Countries
China
Contacts
Public ContactDeng Guofang
Shenzhen Third People's Hospital
Outcome results
None listed