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Found 3 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.
Actively Recruiting
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.