Therapeutic Drug Monitoring (TDM)TuberculosisNCT07607288
Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.
An observational study of Therapeutic Drug Monitoring (TDM) and Tuberculosis, run by Beijing Chest Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Therapeutic Drug Monitoring (TDM), Tuberculosis
- What is being tested?
- Antituberculosis drugs Group
- How many people
- 2,215 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
Beijing, Beijing Municipality, 101149
About this study
Official title: Clinical Study on the Correlation Between Plasma Concentrations of Antituberculosis Drugs and Treatment Efficacy/Safety.
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.
- Conditions
- Therapeutic Drug Monitoring (TDM), Tuberculosis
- Being tested
- Antituberculosis drugs Group
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antituberculosis drugs GroupDrug
Collect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Antituberculosis drugs Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From January 2021 to December 2028 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Drug Monitoring (TDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nie WenJuan, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607288
- Sponsor's protocol ID
- GCP-TB-2026-05-04
- Acronym
- Tuberculosis
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Correlation Between Plasma Concentrations of Antituberculosis Drugs and Treatment Efficacy/Safety.
- ClinicalTrials.gov ID
- NCT07607288
- Acronym / sponsor ID
- Tuberculosis / GCP-TB-2026-05-04
- Conditions
- Therapeutic Drug Monitoring (TDM), Tuberculosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,215 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Drug: Antituberculosis drugs GroupAccording 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antituberculosis drugs GroupCollect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide. | Drug | Study Cohort |
Primary outcome
Correlation between plasma concentrations of antituberculosis drugs and the incidence and severity of adverse events during antituberculosis treatment, particularly hepatotoxicity and cardiotoxicity.
Time frame: From January 2021 to December 2028 .
The primary outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Drug Monitoring (TDM) and Tuberculosis, run by Beijing Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between plasma concentrations of antituberculosis drugs and the incidence and severity of adverse events during antituberculosis treatment, particularly hepatotoxicity and cardiotoxicity. (time frame: From January 2021 to December 2028 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.