Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT07191834
Eligibility Criteria:
Inclusion Criteria:
* Voluntary participation.
* Aged \>12 years, and weighing 30 kilograms or more.
* Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an BPaL treatment regimen.
* The diabetes group shall include patients who have been diagnosed with diabetes, either previously or currently.
* Fertile women shall not be pregnant, voluntarily undergo a pregnancy test with a negative result, and be willing to use highly effective contraceptive measures from the time of signing the informed consent until three months after the end of the research treatment.
* Fertile men shall use condoms or other methods to ensure effective contraception for their sexual partners.
* Lactating women shall be willing to stop breastfeeding from the time of signing the informed consent until three months after the end of the research treatment.
* Participants shall voluntarily undergo an HIV test. If the result is positive, they shall voluntarily accept antiretroviral therapy.
Exclusion Criteria:
* Previously received treatment with at least one of bedaquiline (BDQ) or delamanid (DLM) for more than 28 days.
* Currently using prohibited medications specified in the research protocol, and the researcher believes that, from the perspective of patient benefit, the priority of continuing to use the medication is higher than participating in this study.
* Known to have had a hypersensitivity reaction to any of the medications in the protocol.
* Currently participating in any other clinical trials of medications.
* At the time of screening, there is a risk of cardiovascular disease: QTcF interval exceeding 480 milliseconds; a history of arrhythmia considered clinically significant by the researcher within 60 days before enrollment, and the researcher believes that participation in the study may increase the risk; decompensated heart failure; grade 3 hypertension without reaching the control target; abnormal thyroid function; abnormal levels of serum calcium, magnesium, or potassium.
* A history of optic neuropathy or peripheral neuropathy, and the researcher believes that progression/deterioration may occur during the study, or the participant is not suitable for the study.
* At the time of screening, there are the following manifestations of liver diseases: active viral hepatitis; decompensated cirrhosis.
* At the time of screening, there is a history of the following kidney diseases or manifestations related to kidney diseases: a history of unstable or rapidly progressive kidney disease; moderate/severe renal impairment or end - stage renal disease; serum creatinine ≥133 μmol/L in men and ≥124 μmol/L in women.
* Other abnormal laboratory test results: hemoglobin level \<8.0 g/dL; platelet count \<75,000/mm³; absolute neutrophil count \<1000/mm³; aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>3×ULN; total bilirubin \>2×ULN, or \>1.5×ULN combined with other abnormal liver enzymes; albumin \<30 g/L.
* The researcher believes that the study participant is unable to complete the study process, or participation in the study is unsafe for the study participant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT07191834
Study Brief:
Protocol Section:
NCT07191834