BridgeMD
New treatment option for Mycobacterium Abscessus Pulmonary Disease
Official title TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
ClinicalTrials.gov ID: NCT07295938
What this study is testing
What is Chinese herbs-I?
Chinese herbs-I is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mycobacterium abscessus pulmonary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- Patients undergoing dialysis;
- Patients with radiation pneumonitis requiring corticosteroid or immunoglobulin pulse therapy, or clinically proven active interstitial lung disease...
See the full eligibility 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...
- 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...
- 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...
- 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-treatment) studies or follow-up visits in treatment trials;
- Physical examinations or clinical tests that the investigator deems potentially interfering with results or increasing treatment-related complications.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Guangdong, China
- Hefei, China
- Nanchang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Guangdong, China; Hefei, China; Nanchang, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.