Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring D… (NCT07607288) | Clinical Trial Compass
By InvitationNot Applicable
Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.
China2,215 participantsStarted 2021-01-01
Plain-language summary
The purpose of this clinical trial is to investigate the correlation between anti-tuberculosis drug concentration monitoring and treatment efficacy and safety through analytical studies.The main questions it aims to answer include:
Guidance for individualized dosage adjustment of anti-tuberculosis drugs; Guidance on medication challenges for special populations and patients with comorbidities;Address the dose optimization issue for refractory tuberculosis.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with tuberculosis confirmed by bacteriological or pathological diagnosis;
* Those who have received standardized anti-tuberculosis treatment regimens;
* Patients with complete clinical records and completed follow-up for at least one treatment course.
Exclusion Criteria:
* Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels\>2 times the upper limit of normal;
* Concurrent chronic liver diseases such as chronic hepatitis B, hepatitis C, or alcoholic liver disease;
* Concurrent severe underlying cardiac conditions (e.g.,congenital heart disease, cardiomyopathy, severe arrhythmias);
* Concurrent use of multiple medications that may affect cardiac function;
* Human immunodeficiency virus (HIV) co-infection;
* Women who are pregnant or breastfeeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between plasma concentrations of antituberculosis drugs and the incidence and severity of adverse events during antituberculosis treatment, particularly hepatotoxicity and cardiotoxicity.