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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Cohort | According to the patient's group of core anti-tuberculosis drugs used, record the plasma drug concentrations of each medication at 2 hours post-administration. and Collect the following information through the electronic medical record system:(1) Baseline data: age, sex, height, weight, body mass index (BMI), and albumin levels; (2) Clinical diagnostic information: Type of tuberculosis, Treatment status; (3) Treatment outcomes: cured/completed treatment, treatment failure/death, lost to follow-up; (4) Adverse drug reactions: incidence of adverse reactions, types of adverse reactions (bone marrow suppression, liver injury, kidney injury, cardiac toxicity, peripheral neurotoxicity, psychiatric/psychological adverse reactions, others), and conduct association analyses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antituberculosis drugs Group | Drug | Collect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between plasma concentrations of antituberculosis drugs and the incidence and severity of adverse events during antituberculosis treatment, particularly hepatotoxicity and cardiotoxicity. | The primary outcome | From January 2021 to December 2028 . |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a multicenter, observational clinical study conducted from January 2021 to December 2024 at Beijing Chest Hospital Affiliated to Capital Medical University and Xi'an Eighth Hospital. Tuberculosis patients receiving either initial or relapsed treatment were enrolled and administered standardized anti-tuberculosis regimens. Intravenous blood samples were collected 2 hours after medication administration at weeks 2, 4, 8, 12,16,20, and 24 of treatment. Plasma concentrations of anti-tuberculosis drugs were determined using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The collection time, dosing interval, blood sampling time point, and tested drug types were recorded. Invalid samples with non-standard sampling procedures or missing data were excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute | Beijing | Beijing Municipality | 101149 | China |
In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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