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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating new treatment options for adults with newly diagnosed, drug-sensitive pulmonary tuberculosis through a phase 2BC open-label platform study. The trial compares several experimental drug regimens with a standard control treatment to assess efficacy and safety. Participants include adults aged 18 to 65 years with confirmed pulmonary tuberculosis sensitive to rifampicin and isoniazid. The study aims to optimize doses of existing drugs and introduce new medications to improve treatment outcomes. The study is divided into three stages. In stage 1, participants are randomly assigned to the control or one of two experimental arms containing high-dose rifampicin and other drugs for 12 to 17 weeks. Stage 2 adds an experimental arm including the drug BTZ-043, with participants allocated across four arms in varying ratios. Stage 3 begins after stages 1 and 2 complete enrollment, comparing the control arm with two new experimental arms involving novel drug combinations. Treatments are given once daily, with dosages adjusted by arm and weight. Participants will undergo sputum testing, chest X-rays, and molecular tests to confirm tuberculosis and drug sensitivity before enrollment. During the study, researchers will monitor participants through regular clinical assessments, laboratory tests, and electrocardiograms to track treatment response and safety. The main outcomes measured include time to stable culture conversion and changes in mycobacterial load. Safety is evaluated by recording adverse events and laboratory abnormalities over the treatment period, with follow-up continuing up to 12 months after randomization.
Actively Recruiting
Researchers are investigating chronic kidney disease CKD and related cardiovascular and non-classic risk factors in semi-rural Sub-Saharan Africa. The study aims to fill gaps in knowledge about CKD prevalence, incidence, and risk factors by following a representative group of 1200 adults over time. It seeks to understand how common CKD is, track its development, and explore how traditional and local risk factors interact in this population. This observational study enrolls patients visiting primary care facilities in the Bagamoyo district. Participants undergo three health check-ups at enrollment, after at least 90 days to confirm kidney disease status, and after one year. Data collected include medical history, vital signs, blood and urine tests, kidney ultrasound, and lifestyle information gathered via questionnaires and step counters. These assessments help capture kidney function, cardiovascular health, infections, socioeconomic status, and lifestyle factors. Participants are involved in comprehensive clinical and laboratory evaluations, including measurement of blood pressure, blood glucose, kidney markers, and urine albumin. Questionnaires cover infections, lifestyle, nutrition, and socioeconomic background. Researchers use this data to calculate kidney function and classify CKD stages. The study monitors participants over 18 months to track CKD prevalence and incidence alongside risk factors. Advanced statistical models will be developed to predict CKD risk and disease progression. This longitudinal approach aims to provide detailed information on CKD in the target population.