Klerksdorp

Researchers are evaluating quabodepistat-based treatment regimens for adults and adolescents aged 14 years and older with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis (RR/MDR-TB). This Phase 3, randomized, open-label, multicenter trial aims to determine if quabodepistat combined with other tuberculosis drugs can shorten treatment to 4 months and offer similar or better effectiveness and safety compared to the current 6-month WHO-recommended treatments. The study includes two main groups based on fluoroquinolone sensitivity: fluoroquinolone-sensitive and fluoroquinolone-resistant RR/MDR-TB. Participants will be randomly assigned to receive either experimental or control treatments. For fluoroquinolone-sensitive RR/MDR-TB, the experimental regimen is BPaQM (bedaquiline, pretomanid, quabodepistat, moxifloxacin) for 4 months, compared to the control BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) for 6 months. For fluoroquinolone-resistant RR/MDR-TB, the experimental treatment is BPaQ (bedaquiline, pretomanid, quabodepistat) for 6 months, versus the control BPaL (bedaquiline, pretomanid, linezolid) for 6 months. Drug dosing schedules vary by regimen, with bedaquiline dosing starting with daily doses followed by maintenance doses and all other drugs dosed once daily. Participants will be followed for 16 months after randomization, during which time researchers will assess treatment effectiveness by measuring the proportion of participants with unfavorable outcomes up to 12 months following randomization. Safety and tolerability will be monitored through recording adverse events from the first dose until two weeks after treatment ends. The study includes sputum sample collection, chest X-rays, laboratory tests, and monitoring for side effects. Independent committees oversee data monitoring and outcome adjudication to ensure participant safety and study integrity.

Researchers are evaluating the safety and immune response of the MTBVAC vaccine in adolescents and adults aged 12 to 55 years living with or without HIV in South Africa. The study focuses on comparing MTBVAC to the BCG vaccine and is conducted as a Phase 2a clinical trial. Participants are grouped based on HIV status, CD4+ T cell counts, and IGRA status to better understand the vaccine's effects in different subpopulations. The study is divided into two parts, with Part A including two cohorts and Part B having one cohort, each with four groups. Participants are randomized to receive either a single 0.1 mL injection of MTBVAC or BCG vaccine intradermally. Enrollment in the third cohort will begin only if safety criteria are met for the first two cohorts. All participants receive one dose and are followed for 48 weeks to monitor outcomes. Participants will undergo various assessments throughout the study, including monitoring for adverse events up to 48 weeks and evaluating immune cell responses at baseline and weeks 4 and 10. Researchers will track solicited and unsolicited adverse events, serious adverse events, and Grade 3 or higher adverse events. Safety, immune responses, and overall health will be carefully observed through clinical exams, laboratory tests, and questionnaires during the study period.

People living with HIV face a high risk of poor health outcomes after leaving the hospital. This research is testing whether a structured home care program, with or without added nutritional support, can reduce the chance of death within six months after hospital discharge and improve long-term health. The study is a randomized clinical trial that also looks at how well these care programs are delivered and accepted in real-world settings, especially where resources are limited and HIV is common. Participants are randomly assigned to one of three groups: standard care after discharge, home-based care called HomeLink that includes medical check-ups, support for taking HIV medications, and counseling, or HomeLink plus nutritional support with food parcels. The HomeLink program starts one week after leaving the hospital and involves nurse and counselor visits every two weeks for up to six visits. These visits include health assessments, medication support, psychosocial counseling, specimen collection, and home safety checks. During the study, participants will be followed up through home visits and assessments to track their health and well-being. Researchers will measure outcomes like death rates within six months after discharge and how many people receive and accept the interventions. They will also study the economic impact on households and the costs involved in providing home-based care with or without food support. The goal is to provide evidence to improve care for people living with HIV after hospital stays and to guide health policies and practices.

Researchers are conducting a Phase 3, double-blinded, placebo-controlled, multicenter trial to assess whether azithromycin taken as a preventive treatment can reduce death rates in adults with advanced HIV disease. Participants eligible for the study must have confirmed HIV infection with low CD4 counts or specific treatment histories, reflecting advanced immunosuppression. The trial aims to better understand mortality outcomes related to this preventive approach in this population. Participants will be randomly assigned to receive either azithromycin tablets or placebo tablets for 28 days. All participants will be followed for 24 weeks after randomization to measure the main outcome of death from any cause, with total follow-up lasting 48 weeks. The study compares the effects of azithromycin prophylaxis against an inactive placebo to evaluate its impact on survival. During the study, participants will be monitored regularly to track health outcomes, particularly mortality. They must be able to start or adjust antiretroviral therapy within four weeks of joining the trial. Researchers will closely observe for any adverse effects, treatment adherence, and overall health status throughout the follow-up period to assess the safety and effectiveness of the intervention.

Researchers are evaluating whether Remote Ischaemic Conditioning (RIC) can reduce death and early heart failure within 30 days in patients with ST-segment elevation myocardial infarction (STEMI) in Africa. This trial focuses on higher-risk patients treated mainly with thrombolytic therapy, across about 25 sites in seven African countries. The study includes a randomized controlled trial (RCT) and an observational arm for patients presenting later than 24 hours but less than 72 hours after symptom onset. Patients in the RCT are randomly assigned to either RIC or a sham control. RIC involves four cycles of 5-minute inflation of a cuff on the upper arm to 20 mmHg above systolic blood pressure followed by 5 minutes of deflation, repeated daily for 3 days starting before thrombolysis. The sham control uses a similar device inflated to a low pressure of 20 mmHg for the same schedule. The observational arm includes patients presenting between 24 and 72 hours after symptom onset and follows the same outcome measures. Participants undergo assessments including ECG, biomarkers, and echocardiography to confirm STEMI and monitor outcomes. The primary measure is a combined rate of all-cause death and new heart failure at 30 days after STEMI. The study also monitors safety and collects informed consent, aiming to provide a low-cost, non-invasive therapy to improve outcomes for high-risk STEMI patients in Africa.