Klerksdorp

Researchers are evaluating quabodepistat-containing treatment regimens for adults and adolescents aged 14 years and older with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis RRMDR-TB. The study aims to determine if adding quabodepistat to other TB drugs can shorten treatment duration to 4 months for fluoroquinolone-sensitive TB and provide a safer alternative compared to the current 6-month WHO-endorsed regimens. This Phase 3, randomized, open-label trial also compares treatments for patients with fluoroquinolone-resistant TB. Participants will be divided into two main groups based on fluoroquinolone sensitivity. Those with fluoroquinolone-sensitive RRMDR-TB will receive either an experimental 4-month regimen BPaQM bedaquiline, pretomanid, quabodepistat, moxifloxacin or a 6-month control regimen BPaLM bedaquiline, pretomanid, linezolid, moxifloxacin. Those with fluoroquinolone-resistant RRMDR-TB will receive either an experimental 6-month regimen BPaQ bedaquiline, pretomanid, quabodepistat or a control 6-month regimen BPaL bedaquiline, pretomanid, linezolid. Dosing schedules vary by regimen and last either 4 or 6 months. During the 16-month follow-up, participants will undergo regular assessments including sputum samples, chest X-rays, laboratory tests, and safety evaluations. Researchers will measure treatment effectiveness by the proportion with unfavorable outcomes 12 months after randomization and monitor adverse events. Additional outcomes include time to sputum culture conversion, microbiological relapse, and drug plasma levels. Safety will be closely monitored throughout treatment and follow-up periods.

Researchers are evaluating the safety and immune response of the MTBVAC vaccine in adolescents and adults aged 12 to 55 years living with and without HIV in South Africa. The study includes participants grouped by HIV status and immune markers, such as CD4 T cell counts and interferon-gamma release assay results. The trial is designed to compare MTBVAC with the BCG vaccine and is conducted as a Phase 2a randomized study without a placebo group. The study is divided into two parts Part A includes two cohorts with four groups each, and Part B includes one cohort with four groups. Participants receive a single 0.1 mL intradermal injection of either MTBVAC or BCG in the upper arm at the start of the study. Enrollment of the third cohort will occur only if safety criteria are met in the first two cohorts. Following vaccination, participants are monitored for 48 weeks. Participants will attend clinic visits for safety assessments and immune response evaluations through blood tests measuring specific immune cells and antibodies at various time points, including weeks 4, 10, 24, and 48. Researchers will track adverse events, vaccine acceptability, and immune system changes by analyzing blood samples and gene expression. The study ensures thorough follow-up to assess both the safety and the bodys immune reaction to the vaccines over nearly a year.

People living with HIV who have recently been discharged from the hospital face a higher risk of poor health outcomes, including death. This study evaluates whether providing structured home-based care, with or without nutritional support, can help reduce the risk of death within six months after discharge and improve long-term health. The trial is a randomized clinical study that also looks at how practical and acceptable these home care approaches are in real-world settings. Participants are randomly assigned to one of three groups standard post-discharge care, home-based care with medical assessments and psychosocial support, or home-based care combined with food parcels for nutritional support. The home visits start one week after discharge and occur every two weeks, totaling 4 to 6 visits. Those in the nutritional support group receive three food parcel deliveries at weeks 1, 5, and 9. The care during home visits includes medication adherence support, clinical assessments, lab specimen collection, and counseling. During the study, participants are monitored for mortality up to 12 months after discharge, rehospitalization, viral load suppression, and weight changes. Researchers also assess how well the interventions are delivered, their acceptance by patients and families, and the economic impact of illness on households. The study spans several years, with enrollment starting in 2025 and follow-up continuing through 2029, aiming to provide evidence to improve care for people living with HIV after hospital discharge.

Researchers are evaluating whether taking azithromycin as a preventive treatment can reduce the risk of death in adults with advanced HIV disease. This is a Phase 3, double-blind, placebo-controlled trial involving multiple centers. The study aims to understand if azithromycin prophylaxis can lower mortality compared to a placebo in this vulnerable population. Participants will be randomly assigned to receive either an oral azithromycin tablet or a matching placebo tablet once daily for 28 days. After this treatment period, they will be followed for 24 weeks to measure the main outcome of all-cause mortality. The total study participation will last 48 weeks to monitor both short-term and longer-term effects. During the study, participants will undergo assessments to track survival and hospitalizations at 12 and 24 weeks after starting the treatment. Researchers will closely monitor health outcomes and any hospital stays to evaluate the impact of azithromycin prophylaxis. Safety and adherence will be followed throughout the trial to ensure accurate measurement of results.

The RIC-AFRICA trial is a multi-center, sham-controlled, randomized controlled trial involving 1400 patients who have experienced ST-segment elevation myocardial infarction STEMI within 24 hours of symptom onset. The study aims to find out if Remote Ischaemic Conditioning RIC can reduce death rates and early heart failure after a heart attack in patients mainly treated with clot-busting therapy. It also includes an observational group of patients presenting between 24 and 72 hours after the heart attack to study similar outcomes without treatment intervention. Participants are randomly assigned to either the RIC group or a sham control group. Those in the RIC group will receive four cycles of blood pressure cuff inflation to 20 mmHg above their systolic blood pressure for 5 minutes, followed by 5 minutes of deflation, repeated four times, and this protocol will be repeated daily for two more days. The sham group will undergo the same cycle with low-pressure inflation to 20 mmHg. The observational group, who present later, will not receive intervention but will be followed with the same outcome measures. Throughout the study, participants will be monitored for all-cause death and new onset heart failure within 30 days after the heart attack. Assessments will include clinical evaluations, ECG, biomarkers, and echocardiography to confirm STEMI and heart function. The study will also track major adverse cardiac and cerebrovascular events at 30 days. The total participation duration varies based on the group, with interventions over three days for the randomized groups and observation for up to 72 hours for the non-randomized group.