Liu Pan Shui Shi

This observational study focuses on investigating the proportion of latent tuberculosis infection among students who have been in close contact with active tuberculosis patients in school settings. It aims to identify how common Mycobacterium tuberculosis infection is in these contacts, explore risk factors related to TB infection, and assess the health economic aspects of screening strategies for tuberculosis. Participants will be tested using the QuantiFERON-TB Gold (QFT) test to detect prior infection with Mycobacterium tuberculosis. Those who test positive will undergo additional evaluations including sputum Xpert MTB/RIF testing, physical examinations, chest CT scans, and sputum cultures as needed to distinguish latent TB infection from active tuberculosis. Chest X-ray scans are performed if the participant is older than 15 years and has a positive QFT result. During the study, participants will be monitored through these diagnostic tests and examinations to determine the presence of TB infection. Researchers will measure the prevalence of tuberculosis infection at baseline among school contacts. The study includes students aged 13 years and older who have had close contact with active TB cases in school environments such as classrooms or dormitories. Participation involves signing informed consent, with guardian involvement for minors.

Researchers are evaluating whether shorter treatment regimens are effective for people with asymptomatic tuberculosis. This phase 4, open-label, multicenter randomized controlled trial in China compares the standard 26-week treatment to shorter 17-week and 13-week regimens using different combinations and doses of anti-tuberculosis medications. The goal is to see if treatment duration can be safely reduced without increasing the medication types or doses. Participants will be randomly assigned to one of three groups: the standard regimen group, the four-month (17-week) regimen group, or the three-month (13-week) regimen group. The standard regimen involves 8 weeks of four drugs followed by 18 weeks of two drugs. The four-month group follows the same first 8 weeks, then 9 weeks of two drugs, with possible extension if sputum or imaging results suggest ongoing infection. The three-month group uses high-dose rifapentine, isoniazid, pyrazinamide, and moxifloxacin for 8 weeks, followed by 5 or 13 weeks of continuation treatment based on response, with dose adjustments allowed for intolerance. During the study, participants will be monitored for treatment response through sputum culture and radiological exams at the end of treatment phases. Researchers will measure the favorable outcome rate 78 weeks after randomization. The study includes safety monitoring, and treatment may be extended if infection indicators persist. Participants will be followed for over one year to assess long-term treatment success and safety.

Researchers are evaluating shorter, all-oral treatment regimens for people with rifampicin-resistant tuberculosis (RR-TB), including those with pre-extensively drug-resistant TB (Pre-XDR-TB). This phase 3 trial compares seven different 9-month oral drug combinations to the 9-month standard of care (SOC) for RR-TB patients susceptible to fluoroquinolones. For those resistant to fluoroquinolones, a 9-month bedaquiline-containing regimen is compared to a conventional 20-month treatment. The study aims to assess if these shorter regimens are as effective and safe as the longer standard treatments. The experimental treatments include combinations of bedaquiline, linezolid, fluoroquinolones (moxifloxacin or levofloxacin), cycloserine, clofazimine, pyrazinamide, and other drugs. Each 9-month regimen uses no more than two major QT-prolonging drugs to reduce side effects. Treatment duration may be extended by 2 months if lung cavities remain or cultures are positive at month 2. For patients resistant to pyrazinamide based on baseline molecular testing, that drug is stopped without replacement. The control groups receive the current national guideline regimens, either 9 months for fluoroquinolone-susceptible or 20 months for Pre-XDR-TB. Participants undergo regular assessments including molecular drug susceptibility testing using whole gene sequencing at baseline. Researchers monitor treatment outcomes, safety, and side effects over a total of 21 months after randomization. The main outcome measured is a favorable treatment result at the end of the study. Participants are followed closely with clinical evaluations to understand the effectiveness and tolerability of these shorter, precision-based oral regimens.

Tuberculosis (TB) is a major global infectious disease, and controlling it is challenging due to the difficulty patients have in following long and complex treatment plans. This research aims to evaluate high-dose rifapentine in treating rifampicin-sensitive pulmonary tuberculosis and to explore if the treatment duration can be shortened to 17 weeks. The study is a multicenter, non-inferiority randomized controlled trial conducted in two stages to assess the safety, effectiveness, and drug behavior of different rifapentine doses. Participants will receive one of several treatment regimens: a short regimen with rifapentine at 10mg/kg, 15mg/kg, or 20mg/kg daily combined with isoniazid, pyrazinamide, and moxifloxacin, all taken orally; or a standardized regimen with rifampicin, isoniazid, pyrazinamide, and ethambutol during an intensive phase, followed by rifampicin and isoniazid in the continuation phase. The first stage focuses on determining tolerability and pharmacokinetics to select doses for the second stage, which confirms efficacy and safety. During the study, participants will be monitored over 108 weeks after randomization to assess treatment success and tolerability. Researchers will evaluate drug safety, effectiveness, and pharmacokinetics throughout treatment and follow-up. The trial includes regular assessments to track participants' health and response to therapy, aiming to reduce treatment duration and adverse effects while improving outcomes for patients with rifampicin-sensitive tuberculosis.

Researchers are evaluating tuberculosis (TB) prevention strategies among adolescents and school staff who are close contacts of active pulmonary TB cases. This phase 3, open-label, cluster randomized controlled trial conducted in multiple centers in GuiZhou, China, aims to compare the non-inferiority of a one-month, ultra-short treatment regimen (1H3P3) with a standard three-month regimen (3HR) for latent TB infection (LTBI) in school settings. The study addresses the high risk of TB among adolescents and the need for effective prevention approaches in schools to reduce undiagnosed cases and transmission. Participants with confirmed LTBI will be randomly assigned to receive either the 1H3P3 regimen, consisting of 12 doses of isoniazid and rifapentine given three times a week for four weeks, or the 3HR regimen, which involves daily isoniazid and rifampicin for three months. Close contacts of TB index cases are identified through active screening including QuantiFERON-TB Gold Plus testing, chest X-rays, sputum GeneXpert MTB/RIF tests, and symptom evaluation. The trial will follow participants for two years after treatment to compare outcomes. During the study, participants will undergo regular assessments to monitor for TB disease development confirmed by culture, GeneXpert MTB/RIF, or clinical diagnosis. The primary outcome is the number of participants developing active TB within 24 months after randomization. Safety monitoring and follow-up visits will be conducted throughout the two-year period. This study aims to provide evidence for implementing shorter TB preventive treatments in schools, potentially influencing national TB control policies for adolescents.

Objective: To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage. Design: This study is a multi-center, prospective, double-blinded, randomized controlled trial. Interventions: First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride solution (NaCl), and then the EVD or LD tube was clamped for 2 hours after the injection was completed, then kept open as clinically necessary until the next dose (twice a day).