Traditional Chinese herbal therapy added to continuation treatment for Mycobacterium abscessus lung infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled phase 2 trial enrolls patients with Mycobacterium abscessus pulmonary disease who have completed guideline-recommended initial antibiotic therapy and randomizes them during the continuation phase to receive one of two Chinese herbal formulas or matching placebo alongside standard care. Participants are split into two independent RCT arms based on sputum culture status: RCT-1 includes those with persistently positive cultures and uses 52-week cure rate as the primary endpoint, while RCT-2 enrolls culture-negative patients to evaluate recurrence and clinical outcomes. Investigators will use blinded herbal and placebo preparations, scheduled sputum cultures, imaging, and symptom and quality-of-life measures, with follow-up through at least 52 weeks. The trial is conducted at multiple chest hospitals in China under the sponsorship of Shanghai University of Traditional Chinese Medicine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient diagnosed with Mycobacterium abscessus pulmonary disease;
* Patients have completed the initial phase of treatment as recommended by the guidelines;
* Patients who have given written informed consent
* One week prior to enrollment, organ function levels must meet the following criteria: a. Hemoglobin ≥60g/L; b. Neutrophil count ≥0.5×10\^9/L; c. Platelet count ≥60×10\^9/L; d. Serum total bilirubin ≤3 times the upper limit of normal; e. Aspartate aminotransferase ≤3 times the upper limit of normal; f. Alanine aminotransferase ≤3 times the upper limit of normal; g. Creatinine level below 2 times the upper limit of normal or creatinine clearance ≥60mL/min; h. Urea nitrogen ≤200mg/L; i. Urinary protein \<++, with ≥500mg total protein in 24-hour urine if protein is present; j. Blood glucose: within normal range and/or stable blood glucose control in diabetic patients; k. Cardiac function: no history of myocardial infarction within 6 months; no unstable angina; no severe arrhythmia.

Exclusion Criteria:

* Patients with a drug allergy to the investigational medication;
* Patients infected with two or more non-tuberculous mycobacteria, or those with active pulmonary tuberculosis;
* Patients with a prior history of pulmonary parenchymal organ transplantation;
* Patients with severe conditions such as congenital or acquired immunodeficiency disorders, active malignant tumors (primary or metastatic), or any malignancies requiring chemotherapy or radiotherapy during screening or study;
* Patients undergoing dialysis;
* Patients with radiation pneumonitis requiring corticosteroid or immunoglobulin pulse therapy, or clinically proven active interstitial lung disease, uncontrolled massive pleural effusion, or pericardial effusion;
* Unstable systemic comorbidities (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic or renal dysfunction, neuropsychiatric conditions such as Alzheimer's disease);
* Patients with intestinal dysfunction or malabsorption syndrome;
* Pregnant or breastfeeding women;
* Patients receiving other investigational drugs within 4 weeks prior to first exposure to the study drug;
* Concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or follow-up visits in interventional trials;
* Physical examinations or clinical tests that the investigator deems potentially interfering with results or increasing treatment-related complications.

Where it's running

• Guangzhou Municipal Hospital of Chest Medicine
  Guangdong, China Recruiting
• Anhui Provincial Chest Hospital
  Hefei, China Recruiting
• Longhua Hospital Affiliated Shanghai University of TCM
  Shanghai, China Recruiting
• Shanghai Pulmonary Hospital
  Shanghai, China Recruiting
• Beijing Chest Hospital Affiliated to Capital Medical University
  Beijing, China Not yet recruiting
• China-Japan Friendship Hospital
  Beijing, China Not yet recruiting

Study contacts

• Study coordinator: Shaoyan Zhang
• Email: zhangshaoyan000@163.com
• Phone: +8621-64385700-1307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.