Huai Hua Shi

This clinical trial is studying adults aged 18 to 80 years who have hospital-acquired bacterial pneumonia HABP or ventilator-associated bacterial pneumonia VABP. Researchers aim to compare the effectiveness and safety of two antibiotic treatments to see if Meropenem and Pralurbactam are not worse than Ceftazidime and Avibactam. This is a phase 3, randomized, double-blind, active-controlled study sponsored by Qilu Pharmaceutical Co., Ltd., lasting about 32 days including screening and follow-up. Participants will receive one of two treatments Meropenem and Pralurbactam given as a 3-gram dose every 8 hours with a 120-minute infusion, or Ceftazidime and Avibactam given as a 2.5-gram dose every 8 hours with a 120-minute infusion. The treatment period and follow-up are included within the total study duration. The study uses a quadruple masking method, meaning participants, care providers, investigators, and outcomes assessors do not know which treatment is given. During the study, participants will be monitored for safety and efficacy, including observing the number of participants who die from any cause up to day 14. Screening includes chest X-rays or CT scans to confirm pneumonia signs. The study assesses systemic and respiratory symptoms and tracks survival for at least 28 days. Participants will be followed through visits during the study to record outcomes and ensure adherence to treatment protocols.

Researchers are evaluating the effectiveness of BDB-001 injection combined with cyclophosphamide followed by azathioprine, or combined with rituximab, in inducing remission for patients with active ANCA-associated vasculitis AAV. This phase III clinical trial aims to determine how well these treatments work in comparison to standard therapy with prednisone, focusing on disease remission and safety. Participants will be randomly assigned to receive either BDB-001 injection plus cyclophosphamideazathioprine or rituximab with a prednisone placebo, or a prednisone treatment combined with cyclophosphamideazathioprine or rituximab and a placebo matching BDB-001. All treatments are administered intravenously. The study evaluates disease remission at 24 weeks and sustained remission, relapse rates, kidney function changes, glucocorticoid toxicity, and quality of life over 48 weeks. Throughout the trial, participants will have regular assessments including measurements of disease activity using the Birmingham Vasculitis Activity Score BVAS, kidney function tests, and quality of life questionnaires. Safety and treatment effects will be monitored closely. Total participation lasts up to 48 weeks, with the main outcome measured at 24 weeks to determine remission status.

Researchers are investigating the effects of amlodipine alone versus amlodipine combined with folic acid in Chinese adults aged 45 to 74 years who have H-type hypertension, specific MTHFR 677 genotypes CC or CT, elevated plasma homocysteine levels, and low serum folate. This large, multi-center, randomized, double-blind, double-dummy clinical trial aims to evaluate which treatment better reduces the risk of first ischemic stroke over five years. Participants are first screened and then enter a 2 to 4 week run-in period where they take amlodipine to assess tolerance and compliance. Afterward, eligible participants are randomized by genotype into two groups one receiving amlodipine 5mg daily with a placebo, and the other receiving amlodipine 5mg combined with 0.8mg folic acid daily with a placebo. Other blood pressure medications may be added as needed to reach target blood pressure goals. Follow-up visits occur every three months during the five-year treatment period with medication provided at each visit. Throughout the study, participants undergo interviews, clinical evaluations, and laboratory tests including genetic and blood analyses. Researchers monitor adherence, blood pressure, and cardiovascular health. The main outcome measured is the occurrence of first ischemic stroke by the end of five years. Secondary outcomes include other cardiovascular events and kidney function. Two interim analyses will be conducted during the study to assess progress and safety.

Researchers are evaluating the effects of different amlodipine-based treatments on the risk of first ischemic stroke in Chinese adults aged 45 to 74 years with hypertension and the MTHFR 677 TT genotype. This large, multi-center, randomized, double-blind, triple-dummy controlled trial aims to compare amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate over a 5-year period. The study focuses on preventing ischemic stroke as the primary outcome. Participants first undergo a screening period to confirm eligibility through interviews, clinical evaluations, and lab tests. Those who qualify enter a 2 to 4 week run-in phase with daily amlodipine to check treatment tolerance and compliance. Eligible participants are then randomly assigned to one of three daily oral treatment groups amlodipine alone, amlodipine folic acid, or amlodipine folic acid plus 5-MTHF. Additional antihypertensive medications may be added as needed to control blood pressure. Participants are followed every 3 months for drug distribution and monitoring. Throughout the study, participants will have regular clinical visits, interviews, and biological sample collections to monitor health and treatment effects. Researchers will track the incidence of first ischemic stroke and other cardiovascular and kidney outcomes over five years. Safety and treatment adherence are carefully observed, with two planned interim analyses during the trial. Total participation spans from initial screening through five years of treatment and follow-up.

Researchers are conducting a nationwide, multicenter observational study to establish and improve a hospital-based clinical surveillance and early warning system for respiratory syndrome pathogens. The study will include patients with respiratory syndrome from various hospital settings across seven regions in China. It aims to monitor pathogen trends, support risk assessment, and provide evidence for prevention and control strategies over several years. Participants diagnosed with respiratory syndrome will have clinical data collected every two weeks, including demographics, symptoms, diagnoses, lab tests, medications, oxygen therapy, hospital stays, ICU admissions, and outcomes. For those meeting specific diagnostic criteria, respiratory and other biospecimens will undergo a range of tests including routine pathogen tests, multiplex PCR, targeted and metagenomic sequencing, antibody and cytokine testing, and exploratory multi-omics analyses. During the study, data and specimens will be collected routinely from participants receiving clinical care. Researchers will generate national and regional surveillance reports to support early warnings and prevention efforts. The main outcomes measured include detection rates and types of respiratory pathogens and immune responses after infection or vaccination, tracked over three years. Participation involves regular data reporting through secure channels without additional treatment interventions.

Researchers are studying the safety and effectiveness of early use of tirofiban in patients who have acute ischemic stroke and are treated with tenecteplase. This study is exploring whether adding tirofiban soon after tenecteplase can reduce the risk of blood clot re-blockage in the brain, which happens in some patients after initial treatment. The study is a phase 3 trial aiming to improve stroke outcomes by preventing this reocclusion. Participants first receive tenecteplase intravenously for stroke treatment. Those who meet the study criteria are then randomly assigned to receive either tirofiban or a placebo. Tirofiban or placebo is given intravenously starting as soon as possible after randomization, initially as a higher dose for 30 minutes, followed by a continuous lower dose infusion for nearly 48 hours. After 24 hours, patients receive aspirin andor clopidogrel or their placebos, then after 44 hours, antiplatelet therapy with aspirin andor clopidogrel continues until the 90-day follow-up. During the study, participants undergo assessments including neurological exams and monitoring for bleeding or other adverse events. The main outcome measured is excellent functional recovery 90 days after randomization. Other outcomes include disability levels, neurological improvement, quality of life, bleeding events, and mortality. Safety and serious adverse events are tracked through the 90-day period to evaluate treatment effects and risks.

Researchers are studying the use of Tenecteplase TNK combined with Butylphthalide NBP in patients who have experienced mild disabling acute ischemic stroke AIS. This large, randomized, double-blind trial compares the effects of TNK plus NBP versus TNK alone to see if the combination improves neurological function and recovery. Patients eligible for the study are adults aged 18 to 80 years who have had a stroke within 4.5 hours and meet specific neurological severity criteria. Participants are randomly assigned to one of two groups. The combination group receives a single intravenous dose of TNK followed by intravenous NBP twice daily for 7 days, then oral NBP capsules three times daily until Day 14. The control group receives the same TNK dose followed by a matching placebo infusion and capsules on the same schedule. Treatments are administered during hospitalization and continue after discharge if needed. Throughout the 90-day study period, participants undergo assessments including stroke severity scores, functional recovery measured by the Modified Rankin Scale, quality of life surveys, and imaging to evaluate brain tissue salvage. Safety monitoring tracks adverse events like bleeding or vascular complications. The main outcome is the proportion of patients achieving minimal disability by 90 days, with additional evaluations of neurological improvement and stroke recurrence.

Researchers are evaluating the safety of F573 for injection in patients with various types of liver injury, including drug-induced liver injury DILI, chronic hepatitis B CHB, and intrahepatic cholestatic liver injury. This Phase II randomized, double-blind, placebo-controlled clinical trial aims to understand how F573 affects patients at risk of liver failure due to these injuries. The study is conducted in multiple stages. In the first stage, 25 patients receive different doses of F573 or a placebo via intramuscular injection once daily for 7 days. The second stage enrolls 24 patients treated with F573 or placebo at two dose levels once daily for 14 days. The third stage involves a 28-day treatment period with daily intramuscular injections of F573 or placebo, alongside acetylcysteine injection as basic treatment. Dosages are adjusted based on patient weight and earlier trial results. Participants undergo a screening period of 14 days before treatment and a follow-up period of 90 days after treatment completion. Throughout the study, patients receive various assessments including laboratory blood and urine tests, vital sign monitoring, physical exams, electrocardiograms, liver ultrasounds, and biomarker evaluations. Researchers monitor for adverse events, liver function scores, survival status, and medication use to evaluate safety and effects of the treatment.

Researchers are evaluating the effects of adding low-dose radiotherapy to chemoimmunotherapy as a first treatment for patients with nasopharyngeal carcinoma who have liver metastasis. This phase 2 study aims to understand how well this combination works and its side effects in this patient group. The study focuses on patients aged 18 to 70 years who have specific types of nasopharyngeal cancer and liver metastases. The treatment involves delivering low-dose radiotherapy 1.4 Gy daily for 5 days targeted at liver metastases before starting chemoimmunotherapy. The chemoimmunotherapy includes gemcitabine 1000 mgm on days 1 and 8, cisplatin 80 mgm on day 1, and penpulimab 200 mg on day 1. Participants receive this combined treatment as the first-line therapy to assess its impact on cancer progression and survival. Participants will undergo various assessments during the study, including measuring tumor response according to RECIST criteria and monitoring blood counts and organ function. Researchers will track outcomes such as intrahepatic progression-free survival at one year, overall survival at two years, progression-free survival, response rates at 18 weeks, and adverse event rates over two years. The entire study period extends until June 2027, with planned follow-up to observe treatment effects and safety.