Liu Pan Shui Shi

Researchers are evaluating a new tuberculosis preventive treatment among adolescents and school staff who have been in close contact with active TB cases. This study compares a novel 1-month ultra-short regimen called 1H3P3 with the standard 3-month 3HR regimen, aiming to prevent latent TB infection from progressing to active tuberculosis. The trial is a phase 3, multi-center, open-label, cluster randomized controlled study conducted in school settings in China, with the goal of improving TB prevention strategies for adolescents. Participants are randomly assigned to receive either the 12-dose 1H3P3 regimen of isoniazid and rifapentine taken three times a week for one month, or the 3HR regimen of isoniazid and rifampicin taken once daily for three months. Close contacts of TB cases are screened using blood tests, chest X-rays, sputum testing, and symptom checks to rule out active TB before enrollment. The treatment period lasts either one or three months depending on the group, followed by two years of follow-up to monitor for TB development. During the study, participants will undergo regular assessments including monitoring for active tuberculosis through clinical and laboratory tests, adverse events, treatment adherence, and drug resistance if active TB occurs. The main measurement is the cumulative incidence of active TB over 24 months after treatment begins. Safety and treatment completion rates are tracked throughout. Participation involves screening, treatment administration, and periodic follow-up visits over two years to evaluate outcomes and overall TB prevention effectiveness.

Researchers are studying the rate of Mycobacterium tuberculosis MTB infection among students who have been in close contact with active tuberculosis ATB patients at school. The study also aims to identify risk factors related to tuberculosis infection and evaluate the health economics of the screening strategy. This observational study is sponsored by Huashan Hospital and focuses on school contacts of ATB patients aged 13 years and older. Participants will undergo the QuantiFERON-TB Gold QFT test to determine if they have been infected with MTB. Those who test positive will have further assessments including sputum Xpert MTBRIF testing, physical examination, chest CT scan, and if necessary, sputum culture to differentiate latent TB infection from active tuberculosis. For participants over 15 years old with a positive QFT result, a chest X-ray scan may also be performed. During the study, participants will provide baseline information including age, sex, vaccination history, contact patterns, and medical history through checklists. Researchers will monitor the prevalence of tuberculosis infection at baseline and collect other relevant data. The study is observational, meaning no treatment is provided, and participants will be followed to understand the infection status and related factors. The total study duration extends until the end of 2025.

Researchers are evaluating shorter treatment regimens for people with asymptomatic tuberculosis in this prospective, open-label, multicenter randomized controlled trial. The study aims to determine if reducing the treatment duration to 17 weeks without changing medication types or doses, or to 13 weeks using high-dose rifapentine and moxifloxacin, affects treatment outcomes. The trial uses a centralized randomization method to assign participants evenly across study groups to reduce bias. Participants will be randomly assigned to one of three treatment groups the standard regimen lasting 26 weeks, the four-month regimen lasting 17 weeks, or the three-month regimen lasting 13 to 21 weeks. The standard regimen includes an intensive 8-week phase with rifampicin, isoniazid, pyrazinamide, and ethambutol, followed by 18 weeks of rifampicin and isoniazid. The four-month group follows the same 8-week intensive phase, then 9 weeks of rifampin and isoniazid, possibly extended by 8 weeks if sputum culture or imaging shows ongoing disease. The three-month group uses high-dose rifapentine, moxifloxacin, isoniazid, and pyrazinamide for 8 weeks, then a continuation phase of rifapentine, moxifloxacin, and isoniazid for 5 or up to 13 weeks based on response. During the study, participants will be monitored for treatment response through sputum cultures and radiological exams. Researchers will assess outcome measures such as favorable treatment rates at 78 weeks, relapse rates at 104 weeks, sputum culture conversion at 8 weeks, and adverse events throughout treatment and follow-up. Quality of life, drug resistance, and community transmission risk will also be evaluated. The total study period for each participant includes treatment and long-term follow-up extending beyond two years post-randomization.

The trial investigates treatment options for patients with rifampicin-resistant tuberculosis RR-TB, including those resistant or susceptible to fluoroquinolones. It compares seven different 9-month oral drug combinations to the current 9-month standard of care for fluoroquinolone-susceptible RR-TB, and a 9-month bedaquiline-containing regimen to a 20-month conventional regimen for fluoroquinolone-resistant RR-TB. This Phase 3, randomized, controlled, open-label study aims to evaluate if these new shorter treatments are as effective and safe as existing therapies. Participants susceptible to fluoroquinolones receive one of several oral regimens combining drugs like bedaquiline, linezolid, fluoroquinolones moxifloxacin or levofloxacin, cycloserine, clofazimine, and pyrazinamide. Treatment lasts 9 months, with possible extension by 2 months for certain conditions. For fluoroquinolone-resistant participants, the experimental regimen includes bedaquiline, cycloserine, clofazimine, linezolid, and pyrazinamide for 9 months, compared to a 20-month standard regimen. Drug resistance is tested at baseline to adjust medications accordingly. During the study, participants undergo assessments including sputum culture tests and safety evaluations up to 21 months after randomization. Researchers monitor treatment outcomes such as cure rates, time to culture conversion, adverse effects severity, mortality, and specific drug-related side effects. Participants are followed closely with clinical and laboratory tests to evaluate the effectiveness and safety of these regimens throughout the treatment and follow-up period.

Tuberculosis TB remains a leading infectious disease worldwide, with treatment challenges including poor adherence to long and complex regimens. Researchers are evaluating high-dose rifapentine regimens to treat rifampicin-sensitive pulmonary tuberculosis with the aim of shortening treatment duration and reducing side effects and economic burden. This multicenter, prospective, randomized controlled study focuses on assessing the safety, effectiveness, and pharmacokineticspharmacodynamics of these regimens compared to the standard treatment. The study includes four treatment groups three experimental groups receiving rifapentine at doses of 10mgkg, 15mgkg, or 20mgkg combined with isoniazid, pyrazinamide, and moxifloxacin during an 8-week intensive phase, followed by a continuation phase of 9 weeks with rifapentine, isoniazid, and moxifloxacin and one comparator group receiving the World Health Organizations standard 26-week regimen with rifampicin, isoniazid, pyrazinamide, and ethambutol. The continuation phase may be extended up to 18 weeks if certain treatment response criteria are not met. Participants will be monitored through treatment and follow-up lasting up to 108 weeks after randomization. Researchers will evaluate treatment success rates, culture conversion at various time points, relapse rates, and adverse events throughout the study period. Safety assessments will include laboratory tests and clinical evaluations to monitor tolerability and drug effects, ensuring thorough observation during and after treatment completion.

Researchers are evaluating whether injecting nicardipine directly into the cerebrospinal fluid improves outcomes for patients with cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage. This multi-center, prospective, double-blinded, randomized controlled trial compares two methods of delivering nicardipine through extraventricular drainage EVD or lumbar drainage LD. The study aims to determine which approach leads to a better prognosis for affected patients. Participants in the treatment group receive intrathecal nicardipine injections via EVD or LD catheters. The process involves withdrawing 6 ml of cerebrospinal fluid, injecting 4 ml 4 mg of nicardipine hydrochloride, followed by 2 ml of saline, then clamping the catheter for 2 hours. This dosing is done twice daily. The control group undergoes a simulated procedure without receiving the drug. The drainage tubes remain open as clinically needed between doses. During the study, participants are monitored for outcomes using multiple scales, including the Modified Rankin Scale at 90 and 365 days, Glasgow Outcome Score, MMSE, NIH Stroke Scale, and rates of complications like infections or hemorrhage. Safety is assessed through adverse event tracking. Follow-up visits occur up to one year after treatment. The entire study period spans from the start of treatment to long-term outcome evaluations.