NCT07126639Toborzás még nem indult
A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 17. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Rifampicin-resistant tuberculosis (RR-TB) is characterized by a long treatment course, high incidence of adverse reactions, low cure rate and high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, high incidence of adverse reactions and long treatment course, which leads to poor patient compliance. There is an urgent need for new, effective and safe short-course regimens for drug-resistant tuberculosis. A 6-month short-course oral regimen containing pretomanid was introduced in 2020. However, as pretomanid is not yet available in China, it has not been verified and promoted in China. Pretomanid is expected to be launched in China in 2025, and it is urgent to evaluate the application of the new short-course regimen containing pretomanid in the Chinese population. This study is a prospective, randomized, controlled clinical trial. It plans to include RR-TB patients aged ≥12 years in multiple domestic centers. Under the guidance of rapid molecular drug susceptibility test results, the experimental group will be treated with bedaquiline, pretomanid, linezolid and moxifloxacin for 6 months, while the control group will be treated with bedaquiline, delamanid, linezolid and levofloxacin or bedaquiline, delamanid, linezolid and clofazimine for 6 months, depending on the susceptibility to fluoroquinolones. For patients with unknown susceptibility to fluoroquinolones, bedaquiline, delamanid, linezolid, levofloxacin and clofazimine will be used for 6 months. The efficacy and safety will be evaluated to provide a basis for the introduction and implementation of new short-course regimens for RR-TB in China.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2025. júl. 13.
- Kezdés
- 2025. szept. 1.
- Elsődleges befejezés
- 2027. szept. 30.
- Fő szponzor
- Wuhan Pulmonary Hospital
- Betegségek
- Tuberkulózis
- NCT-szám
- NCT07126639
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 200
- 2025. szept. 1. és az elsődleges befejezés (2027. szept. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Had a history of optic nerve or peripheral nerve lesion, and the investigator considered that it might progress/deteriorate during the study or was not suitable for participating in this study.
- At the screening stage, had the following liver disease manifestations: active viral hepatitis; decompensated stage of liver cirrhosis.
Laborértékek
- Had a known hypersensitivity reaction to any drug in the protocol. Was participating in any clinical trial of other drugs. At the screening stage, had cardiovascular disease risk: QTcF interval over 480 milliseconds; within 60 days before enrollment, had a history of clinically significant arrhythmia that the investigator considered could be clinically significant, and the investigator considered that participating in the study might increase the risk; decompensated heart failure; grade 3 hypertension and not reaching the control target; thyroid dysfunction; abnormal serum calcium, magnesium or potassium levels.
- At the screening stage, had the following kidney disease history or kidney-related manifestations: unstable or rapidly progressive kidney disease history; moderate/severe renal function impairment or end-stage renal disease; male serum creatinine ≥ 133 μmol/L, female serum creatinine ≥ 124 μmol/L.
- Other laboratory test abnormalities: 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 liver enzyme abnormalities; albumin < 30 g/L.
Egyéb
- The investigator considered that the study participants could not complete the study process, or participating in the study was unsafe for the study participants.
Kiket keres a vizsgálat
- he research participants themselves voluntarily signed the informed consent form before being enrolled; for those without full capacity for civil conduct, the consent form was signed by their legal guardians.
- The research participants (and their guardians) indicated their willingness to complete all steps and intervention periods of the study.
- Male or female, aged 12 years or older, weighing 30 kilograms or more. Confirmed cases of pulmonary tuberculosis pathogen, with molecular or phenotypic drug sensitivity results within the past 3 months confirming resistance to rifampicin, and confirmed by the pathogen culture results of sputum collected at the time of enrollment.
- Fertile women not in pregnancy, voluntarily undergoing pregnancy tests, with negative results, and willing to use highly effective contraceptive measures from the time of signing the informed consent until 3 months after the end of the study treatment.
- For fertile men, use condoms or other methods to ensure effective contraception for their sexual partners.
- Women in lactation, willing to stop breastfeeding from the time of signing the informed consent until 3 months after the end of the study treatment.
- Voluntary to undergo HIV testing. If the result is positive, voluntarily accept antiretroviral therapy.
Életkor a regiszterben: 12 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.