TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai University of Traditional Chinese Medicine
About this trial
Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). The investigators aimed to evaluate the efficacy of Chinese herbs as adjunct therapy to improve cure rates or reduce recurrence rates during the continuation phase of MAB-PD treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Chinese herbs-I
DrugThis is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time
Chinese herbs-I placebo
DrugChinese herbs-I placebo
Chinese herbs-II
DrugThis is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease during the continuation phase for a long time
Chinese herbs-II placebo
DrugChinese herbs-II placebo
Treatment groups
352 Participants
are divided into 4 treatment groupsGroup A: Treatment Group-IExperimental treatment 1 intervention
Group B: Control Group-IPlacebo comparator 1 intervention
Group C: Treatment Group-IIExperimental treatment 1 intervention
Group D: Control Group-IIPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical cure rate
Measured the change from the Baseline to the end of treatment. The sputum MAB culture was negative on three consecutive occasions, with at least a one-month interval between each, and there were no subsequent positive results.
Time frame
At the end of 52 weeks of treatment2
Relapse or reinfection rates
Bacterial relapse is defined as the occurrence of at least two cultures and/or molecular biology tests identifying the same pathogenic M. abscessus strain as the initial infection after completing anti-M. abscessus treatment. When necessary, genotyping techniques may be employed to differentiate between relapse and reinfection. Reinfection refers to the emergence of different pathogenic strains or species in at least two positive cultures following the initiation of treatment.
Time frame
At the end of 52 weeks of treatmentSecondary outcomes
1
Time to sputum culture conversion
Measured the change from Baseline to the end of treatment
Time frame
From baseline to 52 weeks post-treatment completion2
Absorption rate of lung lesions
The lung lesion absorption rate is assessed via chest imaging to evaluate changes in pulmonary infection lesions compared to the baseline at 26 and 52 weeks after enrollment. Patients with more than half of their lesions absorbed are classified as showing significant absorption; those with less than half absorption are considered to have absorption; those with no changes are deemed to show no change; and those with enlarged lesions or new lesions are regarded as demonstrating deterioration. The determination of the lung lesion absorption rate is made by professional radiology experts.
Time frame
Baseline, 26 weeks and 52 weeks3
Rate of closure of lung cavities
The lung cavity closure rate is assessed through chest imaging to evaluate changes in lung cavities compared to the baseline at 26 and 52 weeks after enrollment. The clinical criteria for CT changes were as follows: Regarding changes in cavity size, scar healing, block healing, or disappearance were defined as closure. A reduction in cavity size by 1/2 or more was defined as reduction, a reduction in cavity diameter by less than 1/2 was classified as no change, and an increase in the cavity diameter by 1/2 or more was defined as increase. The determination of the lung lesion absorption rate is made by professional radiology experts.
Time frame
Baseline, 26 weeks and 52 weeks4
Pulmonary function tests
Assess the patient's pulmonary function, specifically the changes in FEV1 (L), before treatment, as well as at 26 weeks and 52 weeks post-treatment
Time frame
Baseline, 26 weeks and 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai University of Traditional Chinese Medicine
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Anhui Chest Hospital
Collaborator
Guangzhou Chest Hospital.
Collaborator
Jiangxi Chest Hospital
Collaborator
Beijing Chest Hospital
Collaborator
China-Japan Friendship Hospital
Collaborator
Huashan Hospital
Collaborator
Source ClinicalTrials.gov