Lambarene

Researchers are evaluating a new approach to quickly and accurately identify febrile children at higher risk of life-threatening infections in sub-Saharan Africa. This study compares standard clinical guidelines (IMCI-based strategies) alone to a combination of these guidelines with a rapid test measuring suPAR biomarker levels. The goal is to see if adding this biomarker test improves decisions about whether to admit or discharge children with acute fever and ultimately improves their health outcomes. The trial involves two groups: one following the standard IMCI guidelines and the other using IMCI plus the suPAR point-of-care test. Children aged 2 to under 60 months with fever will be randomly assigned to one of these groups. Blood samples will be collected from all participants, but only the intervention group will have suPAR levels measured during the first clinical assessment. Decisions to admit or discharge will be guided by these tests and clinical signs, with specific suPAR level thresholds used to identify children at moderate or high risk. All children will then have a second clinical assessment for safety and confirmation of decisions. Participants will be followed up on days 3 and 7 after enrollment, with additional checks if their condition worsens. There will also be interviews on day 28 and optionally at day 91 to monitor serious adverse events, hospitalizations, or deaths. Children with respiratory symptoms may join an additional sub-study involving lung sounds and sample collections. The main outcome measured is how appropriate the discharge decisions are within the first seven days after assessment.

Malaria, caused by Plasmodium parasites, is a serious disease leading to high illness and death rates worldwide, especially from Plasmodium falciparum. This parasite is responsible for most malaria deaths, mainly in children under 5 years old in Sub-Saharan Africa. Researchers are exploring a new combination treatment using ZY19489 and ferroquine (FQ) that aims to cure uncomplicated malaria with a shorter, simpler dosing schedule, ideally within one or two days, to improve treatment adherence and reduce disease impact. The study tests the safety and tolerability of the oral combination of ZY19489 and ferroquine given once daily for either one or two days after a fasting period of at least 10 hours. Participants will be divided into three groups, each with up to 12 adults carrying the malaria parasite without symptoms. Some participants will receive the active combination while others may receive a placebo. The total study duration for each person, including screening and follow-up, is about 10 weeks. Participants will be closely monitored for safety by tracking any treatment-emergent side effects from the day of dosing up to 64 days after. During the study, they will undergo scheduled visits for clinical assessments, laboratory tests, and other procedures to evaluate how well they tolerate the treatment. The study aims to gather detailed information on safety, tolerability, and how the drugs behave in the body to support further development of this potential new malaria therapy.

Researchers are evaluating the safety and effectiveness of new treatment combinations compared to the standard regimen for adults newly diagnosed with drug-sensitive pulmonary tuberculosis. This phase 2B/C open-label trial involves multiple stages and experimental treatment arms, including drugs like rifampicin, pyrazinamide, moxifloxacin, BTZ-043, alpibectir, ganfeborole, delpazolid, and others. The study aims to find optimized doses and new drug combinations that could improve treatment outcomes in this population. Participants will be randomly assigned to different treatment groups across three stages. Stage 1 compares the control regimen with two experimental rifampicin-containing regimens. Stage 2 adds a new experimental arm with BTZ-043, adjusting participant allocation ratios accordingly. Stage 3 begins after stages 1 and 2 complete recruitment and compares the control arm with two more experimental arms, including one containing alpibectir and ethionamide. Dosages and drug combinations vary by arm, with regimens administered mostly once daily by mouth. During the study, participants will be monitored up to 26 weeks to assess how quickly their tuberculosis cultures convert to negative and to measure changes in the amount of tuberculosis bacteria. Evaluations include clinical exams, chest X-rays, sputum tests, and safety monitoring. The total number of participants planned is up to 390 adults aged 18 to 65. The study includes thorough follow-up to understand treatment effects and safety in this group.

Researchers are evaluating the effectiveness and safety of different anti-malarial drugs in adults, adolescents, and children with uncomplicated Plasmodium falciparum malaria. This study aims to assess how well these medications kill the malaria parasite and their potential to cure the infection, while also studying how well the drugs are tolerated and how they behave in the body to determine appropriate dosing for future research. The study is a multi-part, multi-center platform trial in Phase 2. Participants may receive one or a combination of oral anti-malarial agents, including INE963, KAE609 (Cipargamin), KLU156 (a combination of KAF156 and lumefantrine), or the standard of care drug Coartem. Treatments are given either alone or in combination, and different parts of the study include specific age and weight groups to evaluate these drugs. The study includes several parts, with participants receiving assigned treatments and being monitored closely. During the study, participants will have their parasite levels checked up to day 7 to measure how quickly the infection clears. On day 29, researchers will evaluate the clinical and parasitological response using polymerase chain reaction (PCR) tests. Participants will undergo various assessments including parasite counts, vital signs, and safety monitoring. The study involves detailed follow-up to assess treatment effectiveness and safety over time, with the total participation duration depending on the study part.